Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EE20/Drospirenone · 1 trial · 1 indication
Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.
Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.
| Arm | Type | Description |
|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | EXPERIMENTAL | In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). |
| Placebo | PLACEBO_COMPARATOR | The participants of the placebo group received inert but identical-appearing, color-matched tablets. |
| Name | Type | Description |
|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | DRUG | 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd |
| Placebo | DRUG | Inert tablet |
Inclusion Criteria: * Women of age 14-45 years * \>1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives * Otherwise healthy, except for the presence of moderate acne * Smokers up to a maximum age of 30 (inclusive) at inclusion Exclusi...
EE20/DRSP is an investigational oral contraceptive being developed for contraception and for treating premenstrual dysphoric disorder (PMDD), acne vulgaris, dysmenorrhea, and endometriosis. It is a small molecule combination product studied in Phase 3 clinical trials.
EE20/DRSP is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting Phase 3 clinical trials to evaluate the drug for contraceptive and other gynecologic indications.
EE20/DRSP is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Multiple Phase 3 trials have been completed, studying its efficacy and safety for contraception and related conditions.
EE20/DRSP has completed four Phase 3 trials. NCT00567164 compared flexible extended regimens to a conventional regimen in 1887 women for contraception. NCT01076582 studied hormone withdrawal symptoms in 592 women. NCT01892904 evaluated dysmenorrhea in 216 women in Japan, and NCT01902264 assessed contraception in 34 Mexican women.
EE20/DRSP is a combination of ethinyl estradiol 20 mcg and drospirenone, and it is being studied in comparison with YAZ, which contains the same hormones. The drug is also known by the code BAY86-5300 in clinical trial records.
EE20/DRSP combines ethinyl estradiol and drospirenone, a progestin. Drospirenone has anti-mineralocorticoid and anti-androgenic activity, which may contribute to its effects on hormone-related conditions. The drug works by suppressing ovulation and altering the uterine lining to prevent pregnancy.