Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Drospirenone, Ethinylestradiol/ Yasmin · 2 trials · 6 indications
RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.
| Arm | Type | Description |
|---|---|---|
| Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | EXPERIMENTAL | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks |
| Drospirenone (DRSP)/Ethinylestradiol (EE) | ACTIVE_COMPARATOR | 1 tablet 0.020 mg EE/3.0 mg DRSP \[YAZ\] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | EXPERIMENTAL | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | EXPERIMENTAL | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | ACTIVE_COMPARATOR | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
| Name | Type | Description |
|---|---|---|
| Drospirenone/Ethinylestradiol/Methyltetrahydrofolate | DRUG | 0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF) |
| Drospirenone/Ethinylestradiol (Yaz) | DRUG | 0.020 mg ethinylestradiol with 3.0 mg drospirenone |
| Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) | DRUG | SH K 00641 A -Active study medication encapsulated tablet |
| SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) | DRUG | Active control encapsulated tablet |
Inclusion Criteria: \- Healthy women between 18 and 40 requesting oral contraception Exclusion Criteria: \- The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study
Drospirenone/ethinylestradiol, marketed as Yasmin, is an oral contraceptive combination. It is also being studied in neural tube defects and postmenopause. The development program includes a Phase 3 trial evaluating an oral contraceptive containing folate for neural tube defects and a Phase 2 study in postmenopausal women with prehypertension.
Drospirenone/ethinylestradiol targets NR3C2 and PGR. Both targets are antagonized by the drug. Drospirenone acts as an antagonist at the mineralocorticoid receptor (NR3C2) and the progesterone receptor (PGR), which underlies its contraceptive and hormonal effects.
Yasmin is developed by Bayer AG, which trades under the ticker BAYRY. Bayer AG is the company responsible for the drospirenone/ethinylestradiol program, including the related drospirenone/17ß-estradiol formulations known as Angeliq and BAY86-4891.
Drospirenone/ethinylestradiol is in Phase 3 development. It is an investigational small molecule and is not described as FDA approved. The program has one completed Phase 3 trial and one completed Phase 2 trial, with no active trials currently listed.
The program includes NCT00468481, a completed Phase 3 trial titled Efficacy and Safety Study for an Oral Contraceptive Containing Folate, which enrolled 385 participants in the United States. It also includes NCT00420342, a completed Phase 2 trial of Angeliq and Prempro on blood pressure and sodium sensitivity in postmenopausal women with prehypertension, enrolling 92 participants.
Yasmin is a brand name for drospirenone/ethinylestradiol. Related alternative names in the same program include drospirenone/17ß-estradiol, marketed as Angeliq and also known as BAY86-4891, as well as drospirenone/ethinylestradiol/methyltetrahydrofolate. These names refer to drospirenone-containing combinations developed by Bayer AG.