Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 91-day Levonorgestrel Oral Contraceptive
91-day Levonorgestrel Contraceptive · 3 trials · 4 indications
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.
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%.
| 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, for a total of 13 weeks. |
| 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. |
| 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. |
| 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. |
| Placebo | DRUG | 1 tablet daily to match experimental arm |
| 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. |
Inclusion Criteria: * Premenopausal, non-pregnant, non-lactating * History of migraine headaches without aura for at least 6 months * History of migraine headaches associated with menstruation * Others as directed by FDA-approved protocol Exclusion Criteria: * History of migraine headaches with a...
The 91-day Levonorgestrel Contraceptive is an extended-cycle oral contraceptive small molecule developed by Teva Pharmaceutical Industries Limited. It is designed to provide contraception across a 91-day cycle rather than the standard 28-day cycle. It has been studied in Phase 2 trials in healthy women and adolescent females.
The 91-day Levonorgestrel Contraceptive is used for contraception and has been evaluated for effects on bone mineral density, hemostatic parameters, and menstrually-related migraine headaches. Its clinical development has focused on these areas in women and adolescent females.
The 91-day Levonorgestrel Contraceptive is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical trials evaluating this extended-cycle oral contraceptive.
The 91-day Levonorgestrel Contraceptive is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. All three of its Phase 2 trials have been completed, and no active trials are currently listed.
The 91-day Levonorgestrel Contraceptive has been studied in three completed Phase 2 trials: NCT01252186, which evaluated hemostatic parameters in healthy women; NCT00924560, which assessed bone mineral density in adolescent females; and NCT00781456, which examined efficacy for menstrually-related migraine headaches.
Yes, the 91-day Levonorgestrel Contraceptive is also known as the 91-day Levonorgestrel Oral Contraceptive. Both names refer to the same extended-cycle oral contraceptive developed by Teva Pharmaceutical Industries Limited.