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/17ß-estradiol is an investigational small molecule being studied for use in postmenopause, specifically in postmenopausal women with prehypertension. It is being evaluated for its effects on blood pressure and sodium sensitivity in this population.
Drospirenone/17ß-estradiol is a combination of drospirenone, a progestin, and 17ß-estradiol, an estrogen. It is being studied for its effects on blood pressure and sodium sensitivity in postmenopausal women with prehypertension.
Drospirenone/17ß-estradiol is being developed by Bayer AG, a pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY.
Drospirenone/17ß-estradiol is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
Drospirenone/17ß-estradiol has been studied in one completed Phase 2 trial, NCT00420342, titled 'Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension.' The trial enrolled 92 postmenopausal women in the United States.
Drospirenone/17ß-estradiol is the active ingredient in the product referred to as Angeliq in clinical trial NCT00420342. The trial compared Angeliq to Prempro in postmenopausal women with prehypertension.