Liletta Drug Information
Generic name: LEVONORGESTREL
Progestin [EPC] Progestin-containing Intrauterine System [EPC]
Uses of Liletta
Contraception
LILETTA is indicated for prevention of pregnancy for up to 8 years.
Heavy Menstrual Bleeding
LILETTA is indicated for the treatment of heavy menstrual bleeding for up to 5 years in patients who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed.
Dosage & Administration of Liletta
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Side Effects of Liletta
Clinical Study Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The data described below reflect exposure of 1,751 generally healthy participants, 16 to 45 years of age, to LILETTA in a large, multi-center contraceptive study conducted in the US. Participants included 1,401 exposed for 1 year and 380 who completed 8 years of use; 58% were nulliparous (mean age 25.1 ± 4.3 years) and 42% were parous (mean age 30.3 ± 6.1 years). Most participants who received LILETTA were Caucasian (78.4%) or Black/African American (13.3%); 14.7% of participants were of Hispanic ethnicity. Mean BMI of LILETTA participants was 26.9 kg/m 2 (range 15.8 – 61.6 kg/m 2 ); 25.1% had a BMI ≥ 30 kg/m 2 of which 5.3% had a BMI ≥ 40 kg/m 2. The data cover more than 80,221 28-day cycles of LILETTA exposure.
The frequencies of reported adverse drug reactions represent crude incidences. The most common adverse reactions during the LILETTA clinical study on contraception (occurring in ≥ 5% of participants) are shown in Table 6. The most common adverse reactions during the first year of use were acne (11.4%), bacterial vaginitis (9.0%), and vulvovaginal mycotic infection (7.9%). Table 6: Adverse Reactions in ≥ 5% of LILETTA Participants in the Phase 3 Clinical Study on Contraception Adverse Reaction % LILETTA Participants (N = 1, 751) Vulvovaginal mycotic infections 20.2% Vaginal bacterial infections 19.2% Acne 15.5% Nausea or vomiting 10.5% Headache 10.1% Breast tenderness or pain 10.1% Abdominal discomfort or pain 10.0% Dyspareunia 9.6% Anxiety 9.6% Depression 9.1% Pelvic discomfort or pain 8.7% Dysmenorrhea 7.3% Mood changes 6.5% Back pain 6.5% Weight increased 6.1% Vaginal discharge 5.8% In the clinical study, 20.1% of LILETTA participants discontinued prematurely due to an adverse reaction. The most common adverse reactions reported by participants as reason for discontinuation were expulsion (4.1%), bleeding complaints (2.5%), acne (1.4%), dysmenorrhea (1.0%), weight increased (1.0%), mood swings (0.8%), uterine spasm (0.7%), dyspareunia (0.6%) and pelvic pain (0.6%). Two participants discontinued the clinical study due to PID and one due to endometritis.
The most common adverse reactions reported by participants as reason for discontinuation during the first year of use were expulsion (2.9%) and acne (0.7%). In the clinical study, serious adverse reactions related to LILETTA were ectopic pregnancies, ovarian cysts, and IUS perforation requiring laparoscopic surgery. In the LILETTA clinical study on heavy menstrual bleeding, which included 105 participants who were 18- to 50-years old, the adverse reaction profile was consistent with the adverse reaction profile for LILETTA participants in the contraception study as shown in Table 6. Approximately 11% of LILETTA study participants discontinued prematurely due to an adverse reaction. The most common adverse reactions leading to discontinuation were expulsions (4.8%) and bleeding pattern alterations (3.8%).
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of LNG-releasing IUSs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli, deep vein thrombosis, and stroke Hypersensitivity (including rash, urticaria, and angioedema) Increased blood pressure Dizziness Device breakage
Warnings & Cautions for Liletta
Ectopic Pregnancy Evaluate patients for ectopic pregnancy if they become pregnant with
LILETTA in place because the likelihood of a pregnancy being ectopic is increased with use of an IUS. Approximately half of pregnancies that occur with an IUS in place are likely to be ectopic. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or new onset bleeding in an amenorrheic patient. If an ectopic pregnancy is confirmed, LILETTA should be removed.
The incidence of ectopic pregnancy in the clinical study on contraception with LILETTA, which excluded participants with a history of ectopic pregnancy who did not have a subsequent intrauterine pregnancy, was approximately 0.12 per 100 women-years. There were no ectopic pregnancies in the clinical study on heavy menstrual bleeding with LILETTA. The risk of ectopic pregnancy in patients who have a history of ectopic pregnancy and use LILETTA is unknown. Patients with a previous history of ectopic pregnancy, tubal surgery, or pelvic infection have a higher risk of ectopic pregnancy.
Ectopic pregnancy may require surgery and may result in loss of fertility. Patients who use LILETTA should be informed about recognizing the signs and symptoms of ectopic pregnancy and promptly reporting them to their healthcare professional, and about the associated risks of ectopic pregnancy (e.g., loss of fertility).
Intrauterine Pregnancy
If pregnancy occurs while using LILETTA, determine if LILETTA is in the uterus. If LILETTA is in the uterus, attempt to remove LILETTA because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of LILETTA or probing of the uterus may also result in spontaneous abortion.
In the event of an intrauterine pregnancy with LILETTA, consider the following: Septic A bortion If a patient becomes pregnant with an IUS in place, septic abortion—potentially including septicemia, septic shock, and death—may occur. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination.
Should severe infection of the uterus occur, hysterectomy may be required, which will result in permanent infertility. LILETTA is contraindicated in patients who have had an infected abortion in the prior 3 months. Continuation of P regnancy If a patient becomes pregnant with LILETTA in place and if LILETTA cannot be removed or the patient chooses not to have it removed, warn the patient that failure to remove LILETTA increases the risk of miscarriage, sepsis, premature labor, and premature delivery.
Prenatal care should include counseling about these risks and instructions to immediately report any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid, or any other symptom that suggests complications of the pregnancy.
Sepsis Severe infection or sepsis, including Group
A streptococcal sepsis (GAS), have been reported following insertion of LNG-releasing IUSs. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections.
Aseptic technique during insertion of LILETTA is essential to minimize serious infections such as GAS.
Pelvic Inflammatory Disease or Endometritis Insertion of
LILETTA is contraindicated in the presence of known or suspected PID or endometritis. As well, it is contraindicated in patients with untreated acute cervicitis or vaginitis (including bacterial vaginosis), known chlamydial or gonococcal cervical infection, or other known lower genital tract infections, until the infection is controlled. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion.
Assess risk factors for infection accordingly. Patients who use LILETTA should be counseled to promptly notify a healthcare professional if they develop lower abdominal or pelvic pain, fever, chills, unusual or malodorous discharge, unexplained bleeding, genital lesions or sores, or dyspareunia. In such circumstances, perform a pelvic examination promptly to evaluate for possible pelvic infection.
Remove LILETTA in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment. In the clinical study on contraception with LILETTA, pelvic infection was diagnosed in 0.8% of participants. Pelvic infection was diagnosed as PID in 0.5% of participants and as endometritis in 0.3% of participants.
Infections occurred following variable duration-of-use. One participant diagnosed with PID and two participants diagnosed with endometritis developed the infection within a week of LILETTA insertion. One case of endometritis was diagnosed at 39 days after LILETTA insertion.
The remaining 11 cases of PID and endometritis were diagnosed more than six months after insertion, including one at 30 days after IUS removal. In the clinical study on heavy menstrual bleeding with LILETTA, there was one participant diagnosed with PID approximately 5 months after LILETTA insertion. Patients at Increased Risk for PID or Endometritis PID and endometritis are often associated with a sexually transmitted infection (STI), and LILETTA does not protect against STIs.
The risk of PID or endometritis is greater for patients who have multiple sexual partners, and for patients whose sexual partner(s) have multiple sexual partners. Patients who have had PID or endometritis are at increased risk for recurrence or re-infection. Other risk factors for these infections include unprotected sex and acquired immune deficiency syndrome (AIDS). Asymptomatic PID or Endometritis PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae.
Treatment of PID or Endometritis In IUS users with suspected or diagnosed PID or endometritis, obtain microbial specimens, including those for sexually transmitted infections, and initiate antibiotic treatment promptly. After initiation of antibiotic treatment, the IUS may be removed or kept in place. The patient should continue to receive antibiotic treatment according to current recommendations and should have close clinical follow-up.
Guidelines for PID or endometritis treatment are available from the Centers for Disease Control (CDC), Atlanta, Georgia. 1 If the patient opts for discontinuing IUS use, remove LILETTA after initiation of antibiotic treatment to avoid the potential risk for bacterial spread resulting from the removal procedure. If the patient opts for ongoing IUS contraception, the patient may forego immediate removal of LILETTA after initiation of antibiotic treatment. However, the patient should have close clinical follow-up.
If no clinical improvement occurs within 48–72 hours of initiating treatment, IUS removal is appropriate with continued antibiotic therapy, as indicated. In the LILETTA clinical study on contraception, 12 of the 14 participants who developed PID or endometritis were successfully treated without removal of LILETTA (one of the 14 participants developed PID 30 days after removal). Actinomycosis Actinomycosis has been associated with IUS use. Symptomatic patients with known actinomycosis infection should have LILETTA removed and receive antibiotics.
Actinomycetes can be found in the genital tract cultures in healthy patients without IUSs. The significance of actinomyces-like organisms on Pap test in an asymptomatic IUS user is unknown, and so this finding alone does not always require LILETTA removal and treatment. When possible, confirm a Pap test diagnosis with cultures.
Perforation Perforation (total or partial, including penetration/embedment of
LILETTA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may also occur at any time during IUS use. Perforation may reduce contraceptive efficacy and result in pregnancy.
This may be associated with severe pain and continued bleeding. The risk of perforation may be increased if an IUS is inserted when the uterus is fixed retroverted or not completely involuted during the post-partum period. Delay LILETTA insertion a minimum of four weeks or until involution is complete following a delivery or a second trimester abortion.
If perforation is suspected the IUS should be removed as soon as possible, surgery may be required. Delayed detection or removal of LILETTA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. In a large prospective comparative non-interventional cohort study with another IUS the incidence of uterine perforation was reported as 6.3 per 1,000 insertions for lactating participants, compared to 1.0 per 1,000 insertions for non-lactating participants.
The incidence of perforation during or following LILETTA insertion in the clinical studies, which excluded breastfeeding participants, was 0.1%.
Expulsion Partial or complete expulsion of
LILETTA may occur, resulting in the loss of contraceptive protection. In the clinical study on contraception with LILETTA, an overall expulsion rate of 4.1% over 8 years was reported, with a rate of 2.4% in nulliparous participants and 6.4% in parous participants. The majority (70.4%) occur in the first 12 months, with 23.9% occurring in the first three months and 42.3% in the first six months, cumulatively.
Risk of expulsion is increased for patients with a history of heavy menstrual bleeding or greater than normal BMI at the time of insertion. In the clinical study on heavy menstrual bleeding with LILETTA, 8.6% of participants experienced expulsions, with two-thirds occurring within the first 90 days. About 90% of the expulsions occurred in overweight or obese participants.
Expulsion may be associated with symptoms of bleeding or pain, or it may be asymptomatic and go unnoticed. LILETTA typically decreases menstrual bleeding over time; therefore, an increase in menstrual bleeding may be indicative of an expulsion. Consider further diagnostic imaging, such as sonography or X-ray, to confirm expulsion if LILETTA is not found in the uterus.
The risk of expulsion is increased with insertions performed immediately after delivery; it appears to be increased with insertions performed after second-trimester abortion, based on limited data. Remove a partially expelled LILETTA. If expulsion has occurred, a new LILETTA may be inserted when there is reasonable certainty the patient is not pregnant.
Ovarian Cysts
The contraceptive effect of LILETTA is mainly due to its local effects within the uterus; therefore, ovulatory cycles with follicular rupture usually occur in patients of fertile age using LILETTA. Most ovarian cysts that occur during use of LNG-releasing IUSs are asymptomatic and disappear spontaneously during two to three months of observation. Cysts that cause clinical symptoms can result in pelvic or abdominal pain or dyspareunia. In the clinical study on contraception, symptomatic ovarian cysts occurred in 4.7% of participants using LILETTA over the course of 8 years, and 0.3% of participants discontinued use of LILETTA because of an ovarian cyst.
In the clinical study on heavy menstrual bleeding, symptomatic ovarian cysts occurred in 1.0% of participants using LILETTA over the course of 6 months. Evaluate persistent ovarian cysts. Surgical intervention is not usually required, but may be necessary in some cases, and occurred in 1 (0.06%) of participants in the LILETTA study.
Discuss this risk with patients, as indicated.
Bleeding Pattern Alterations
LILETTA can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea, and amenorrhea. During the first three to six months of LILETTA use, the number of bleeding and spotting days may increase and irregular bleeding patterns may develop. Thereafter, the number of bleeding and spotting days usually decreases but bleeding may remain irregular.
Contraception Study The amenorrhea rates observed in the LILETTA clinical study on contraception are shown in Table 2. The bleeding and spotting days, based on 28-day cycle equivalents, are shown in Table 3. In this study, 2.5% of participants discontinued LILETTA due to bleeding complaints. Table 2: Amenorrhea Rates Last 90-Day Interval of Year Year 1 2 3 4 5 6 7 8 Amenorrhea Rate* 19% 27% 37% 37% 40% 40% 39% 39% *Amenorrhea is defined as no bleeding and/or spotting. Table 3: Bleeding and Spotting Days per 28-Day Cycle Equivalent 28- D ay Cycle Equivalent N* Cycle 1 N=1,691 Cycle 4 N=1,5 93 Cycle 7 N=1, 519 Cycle 13 N= 1,395 Cycle 26 N= 1,109 Days on treatment 1-28 85-112 169-196 337-364 674-728 Mean SD Mean SD Mean SD Mean SD Mean SD Number of bleeding days 5.8 5.2 2.3 3.3 1.6 2.7 1.2 2.4 0.8
Number of spotting days 9.0 5.9 4.3 4.2 3.2 3.6 2.7 3.4
1.9 2.8 *N includes all LILETTA participants in the clinical study on contraception. Heavy Menstrual Bleeding Study The amenorrhea rates observed in the LILETTA clinical study on heavy menstrual bleeding (HMB) are shown in Table 4. Amenorrhea developed in 19% of LILETTA study participants by Cycle 6. Table 4: Amenorrhea Rates for 28-Day Treatment Cycles 28-Day Cycle N Baseline N=87 Cycle 1 N=87 Cycle 2 N=88 Cycle 3 N=88 Cycle 4 N=82 Cycle 5 N=82 Cycle 6 N=79 Amenorrhea Rate* 0% 3% 8% 11% 13% 17% 19% *Amenorrhea is defined as no bleeding and/or spotting. Percentages within each cycle are based on the number of participants who completed the cycle.
The bleeding and spotting days, based on 28-day cycle equivalents, are shown in Table 5. In this study, 3.8% of LILETTA participants discontinued due to bleeding complaints. Table 5: Bleeding and Spotting Days from Baseline to Treatment Cycle 3 and Cycle 6 28-Day Cycle N* Baseline N=87 Cycle 3 N=88 Cycle 6 N=79 Mean SD Mean SD Mean SD Number of Bleeding Days 4.9 1.5 3.7 3.8 2.2
Number of Spotting Days 1.8 1.1 7.3 7.0 5.1 5.8 *N includes
participants with at least one complete 28-day cycle of product-use. Calculations are based on complete 28-day cycles (at least 23 days in length). Resumption of Menses After Discontinuation In the LILETTA clinical study on contraception, 651 of 652 (99.8%) participants 16-35 years of age at enrollment that were evaluated resumed menses after LILETTA removal. This excludes twelve participants (9 became pregnant, 2 had a hysterectomy, and 1 had ovulatory dysfunction). Other Bleeding Pattern Changes If a significant change in bleeding develops during prolonged use, conduct diagnostic tests to assess possible endometrial pathology.
Consider the possibility of pregnancy, including ectopic pregnancy, if menstruation does not occur within six weeks of the onset of a previous menstruation. After excluding pregnancy, repeat pregnancy tests are generally not necessary in amenorrheic patients unless indicated by other signs of pregnancy or pelvic pain.
Breast Cancer Patients who currently have or have had breast cancer, or
have a suspicion of breast cancer, should not use hormonal contraception, including LILETTA, because some breast cancers are hormone-sensitive . Spontaneous reports of breast cancer have been received during postmarketing experience with LNG-releasing IUSs. Observational studies have not provided consistent evidence of an increased risk of breast cancer with use of an LNG-releasing IUS. 5.10 Clinical Considerations for Use and Removal Obtain a complete medical and social history, including partner status, to determine conditions that might influence the selection of an IUS for contraception. Exclude underlying endometrial pathology (e.g., polyps or cancer) prior to the insertion of LILETTA in patients with persistent or uncharacteristic bleeding because irregular bleeding/spotting is common during the first months of LILETTA use and may preclude adequate assessment after insertion.
LILETTA is contraindicated in patients with uterine bleeding of unknown etiology. Exclude underlying congenital or acquired uterine anomalies, including leiomyomas, that distort the uterine cavity and would be incompatible with correct IUS placement . Ensure a previously inserted IUS has been removed prior to insertion of LILETTA. Assess whether the patient is at increased risk of pelvic infection (e.g., unprotected sex, history of PID, or acquired immune deficiency syndrome ). LILETTA does not protect against HIV/STI transmission . Use LILETTA with caution after careful assessment if any of the following conditions exist, and consider removal of the IUS if any of them arise during use: Coagulopathy or use of anticoagulants Migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia Exceptionally severe or frequent headache Marked increase of blood pressure Severe arterial disease such as stroke or myocardial infarction Consider removing LILETTA if any of the following conditions arise during use : Uterine or cervical malignancy Jaundice If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. Consider the possibility that the IUS may have been displaced, (e.g., expulsed or perforated the uterus) . Exclude pregnancy and verify the location of LILETTA by an appropriate diagnostic method (e.g., ultrasonography, X-ray, or gentle exploration of the cervical canal with a suitable instrument) . If LILETTA is displaced, remove it.
A new LILETTA may be inserted at that time or during the next menses if it is certain that conception has not occurred. If LILETTA is in place with no evidence of perforation, no intervention is indicated. 5.11 Magnetic Resonance Imaging (MRI) Information LILETTA is MR-Safe. LILETTA is compatible with MRI and should not interfere with imaging.
Drug Interactions with Liletta
No drug-drug interaction studies have been conducted with LILETTA.
Pregnancy Safety for Liletta
Pregnancy Risk Summary LILETTA is contraindicated for use in pregnant patients and LILETTA may cause adverse pregnancy outcomes. If a patient becomes pregnant with LILETTA in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery. Published studies report no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins in a pregnant patient.
There have been isolated cases of virilization of the external genitalia of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place. Animal reproduction studies have not been conducted with LILETTA. The background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.
Pediatric Use of Liletta
Pediatric Use Safety and effectiveness of LILETTA have been established in females of reproductive potential. The safety and effectiveness are expected to be the same for postpubertal females under the age of 16 as for users 16 years and older. The LILETTA clinical study on contraception included 11 participants who were 16 to 17 years of age; no differences in safety or effectiveness were identified in these participants through 8 years of use of LILETTA. Use of this product is not indicated before menarche.
Contraindications for Liletta
is contraindicated when one or more of the following conditions exist: Pregnancy For use as post-coital contraception (emergency contraception) Congenital or acquired uterine anomaly, including leiomyomas, that distorts the uterine cavity and would be incompatible with correct IUS placement Acute pelvic inflammatory disease (PID) Postpartum endometritis or infected abortion in the past 3 months Known or suspected uterine or cervical malignancy Known or suspected breast cancer or other hormone-sensitive cancer, now or in the past Uterine bleeding of unknown etiology Untreated acute cervicitis or vaginitis, including bacterial vaginosis, known chlamydial or gonococcal cervical infection, or other lower genital tract infections until infection is controlled Acute liver disease or liver tumor (benign or malignant) Conditions associated with increased susceptibility to pelvic infections A previously inserted IUS that has not been removed A history of hypersensitivity reaction to any component of LILETTA. Reactions may include rash, urticaria, and angioedema . Pregnancy Use for post-coital contraception (emergency contraception) Congenital or acquired uterine anomaly that distorts the uterine cavity and would be incompatible with correct IUS placement Acute pelvic inflammatory disease (PID) Postpartum endometritis or infected abortion in the past 3 months Known or suspected uterine or cervical malignancy Known or suspected breast cancer or other hormone-sensitive cancer Uterine bleeding of unknown etiology Untreated acute cervicitis or vaginitis or other lower genital tract infections Acute liver disease or liver tumor (benign or malignant) Increased susceptibility to pelvic infections A previously inserted IUS that has not been removed Hypersensitivity to any component of LILETTA
Clinical Studies of Liletta
Clinical Study on Contraception
The efficacy of LILETTA for contraception was studied in a multicenter, randomized, open-label clinical study conducted in the US that enrolled 1,910 generally healthy participants aged 16 to 45 years, 1,751 of whom received LILETTA. LILETTA was inserted in 1,011 (58%) nulliparous and 740 (42%) parous participants. Participants with a history of ectopic pregnancy, PID, or trophoblastic disease without a subsequent intrauterine pregnancy, who were less than 4 weeks post-pregnancy, had HIV, or were not in a mutually monogamous relationship at study entry were excluded. The demographic profile of enrolled participants who received LILETTA are as follows: White 78.4%, Black or African American 13.3%, Asian 3.9%, American Indian or Alaska Native 1.2%, Native Hawaiian or Other Pacific Islander 0.3%; 2.9% identified multiple races; 14.7% indicated Hispanic ethnicity.
The clinical study had no limit on weight (minimum or maximum) or BMI (range was 15.8 – 61.6 kg/m 2 ). The mean BMI of LILETTA participants was 26.9 kg/m 2 ; 24% were overweight, 24% were obese (BMI ≥ 30 kg/m 2 ), and 5% were morbidly obese (BMI ≥ 40 kg/m 2 ). The pregnancy rate calculated as the Pearl Index (PI) in participants 16 to 35 years of age, inclusive, was the primary efficacy endpoint used to assess contraceptive reliability. The PI was calculated based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which back-up contraception was used unless a pregnancy occurred in that cycle. The Year 1 PI was based on two pregnancies and the cumulative 8-year pregnancy rate was calculated by the life table method, based on a total of eleven pregnancies that occurred after the onset of treatment and within 7 days after LILETTA removal or expulsion.
Table 8 shows the annual PI for each of the eight years and the calculated cumulative life table pregnancy rates through years 1, 2, 3, 4, 5, 6, 7, and 8. For Year 7 and Year 8, participants who were more than 39 years of age at the beginning of the respective study year were excluded from the efficacy analysis. Table 8: Contraceptive Efficacy: Pregnancy Rates L ILETTA Clinical Study Number of 28-Day Cycles of Exposure By Year Year-by-Year Pearl Index Pregnancy Rate (95% CI) Cumulative 28-Day Cycles of Exposure Cumulative Year Life Table Pregnancy Rate (95% CI) Year 1 17,175 0.15 17,175 0.14 Year 2 14,205 0.37 31,380 0.50 Year 3 11,760 0.11 43,140 0.60 Year 4 9,891 0.13 53,031 0.73 Year 5 8,337 0.16 61,368 0.89 Year 6 6,916 0.00 68,284 0.89 Year 7* 5,280 0.49 73,564 1.37 Year 8* 3,657 0.00 77,221 1.37 *Excludes participants >39 years of age at the beginning of the respective year. Conception rates after the removal of LILETTA were assessed and appeared consistent with conception rates in the general population having regular unprotected sexual intercourse for 12 months.
Of 244 participants who desired pregnancy after study discontinuation, 63.1% conceived within 6 months after removal of LILETTA and 83.2% conceived within 12 months after removal of LILETTA.
Clinical Study on Treatment of Heavy Menstrual Bleeding
The efficacy of LILETTA in the treatment of heavy menstrual bleeding was studied in a non-comparative, open-label clinical study conducted in the US. The study enrolled 105 generally healthy participants 18 to 50 years of age, with no contraindications to LILETTA, and with confirmed heavy menstrual bleeding (≥ 80 mL menstrual blood loss per menses) determined using the alkaline hematin method. Participants with any structural (e.g., leiomyomas > 2 cm in greatest diameter or more than 3 leiomyomas > 1.5 cm in greatest diameter) or diagnosed pathophysiologic conditions that may cause heavy uterine bleeding were excluded. The study population was 64.8% White, 23.8% African American, and 11.4% Other; 9.5% of enrolled participants were of Hispanic ethnicity.
The median BMI was 29.7 kg/m 2 (with 23.8% overweight and 48.6% obese). The median baseline MBL was 143.2 mL. The primary efficacy endpoint was the proportion of women with successful treatment, defined as an end-of-study MBL volume < 80 mL and ≥ 50% reduction in MBL from baseline to end-of-study. Treatment outcomes with LILETTA are summarized in Figures 17 and 18. The proportion of participants meeting both criteria defining successful treatment was 80% at the end of the study, with a 95% confidence interval of 71-88% (Figure 17). The quantitative reduction in median MBL volume from baseline to mid-study and to end-of-study is shown in Figure 18. The median MBL percent reduction from baseline to mid-study was 91% and to end-of-study was 96%.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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