drugset / Trial / NCT01331655
Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational product is provided in a blister package or a compliance aiding dispenser with a pill reminder function. The third treatment arm will be a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.
Timeline
- Start
- 2013-04
- Primary completion
- 2014-11
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5-MTHF | Unknown | 0.451 mg | Oral |
| Subject | EE | Unknown | 0.02 mg | Oral |
| Subject | drospirenone | Unknown | 3 mg | Oral |
Indications
No indication recorded.