Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
91-day Levonorgestrel Contraceptive · 3 trials · 4 indications
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. Percent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline \* 100%.
The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.
| Arm | Type | Description |
|---|---|---|
| 91-day Levonorgestrel Oral Contraceptive | EXPERIMENTAL | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. |
| 28-day Levonorgestrel Oral Contraceptive | ACTIVE_COMPARATOR | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
| 28-day Desogestrel Oral Contraceptive | ACTIVE_COMPARATOR | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
| Untreated Control | NO_INTERVENTION | Participants received no oral contraceptives during the study. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks. |
| Name | Type | Description |
|---|---|---|
| 91-day Levonorgestrel Oral Contraceptive | DRUG | 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE. |
| 28-day Levonorgestrel Oral Contraceptive | DRUG | 21 combination tablets containing 150 µg LNG/30 µg EE. |
| 28-day Desogestrel Oral Contraceptive | DRUG | 21 combination tablets containing 150 µg DSG/30 µg EE. |
| Placebo | DRUG | 1 tablet daily to match experimental arm |
Inclusion Criteria: * Premenopausal, non-pregnant, non-lactating women age 18-40 years old * Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m² * Regular spontaneous menstrual cycle * Others as dictated by FDA-approved protocol Exclusion Criteria: * Any condition which contraindicates the use of comb...
91-day Levonorgestrel Contraceptive is an investigational small molecule oral contraceptive being studied for effects on bone mineral density, menstrually-related migraine headaches, and hemostatic parameters in women. It is a 91-day extended cycle oral contraceptive, meaning it is designed to reduce the frequency of menstrual periods.
91-day Levonorgestrel Contraceptive is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's effects on bone mineral density, migraine, and hemostasis.
91-day Levonorgestrel Contraceptive is in Phase 2 clinical development. It is investigational and has not been approved by regulatory authorities. All three completed trials were Phase 2 studies, and the drug remains under investigation for its potential effects on bone mineral density, migraine, and hemostasis.
91-day Levonorgestrel Contraceptive has been studied in three completed Phase 2 trials: NCT00781456 evaluated its effect on menstrually-related migraine headaches in 109 women; NCT00924560 assessed bone mineral density in 1,361 adolescent females; and NCT01252186 examined hemostatic parameters in 265 healthy women.
91-day Levonorgestrel Contraceptive is a small molecule that contains levonorgestrel, a progestin hormone. It works by suppressing ovulation and altering the uterine lining to prevent pregnancy, though the clinical trials listed focus on its secondary effects on bone mineral density, migraine, and hemostasis rather than contraceptive efficacy.
91-day Levonorgestrel Contraceptive is an extended cycle oral contraceptive regimen that uses levonorgestrel, similar to products like Seasonale. However, the specific formulation and dosing schedule may differ, and the drug is currently investigational in Phase 2 trials, so it is not yet marketed under a brand name.