drugset / Trial / NCT03091595
E4/DRSP Ovarian Function Inhibition Study
RandomizedParallel-groupOpen-labelPrevention
Summary
A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24 days followed by 4 placebo tablets, is being evaluated for further development. This study will investigate the effect of this COC on ovarian function inhibition, levels of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.
Timeline
- Start
- 2017-02-07
- Primary completion
- 2018-06-08
- Completion
- 2018-06-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 15 mg | Oral |
| Comparator | ethinyl estradiol | Small molecule | 20 ug | Oral |
| Comparator | drospirenone | Unknown | 3 mg | Oral |
Indications
No indication recorded.