Conditions: Hemostasis Oral Contraceptive
Keywords: Contraception Hemostasis Blood Coagulation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 293
Healthy volunteers: yes

Brief summary:
This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.

Detailed description:

Arms:
arm 1: 21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles arm 2: 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles

Interventions: intervention 1: desogestrel/ethinyl estradiol and ethinyl estradiol intervention 2: desogestrel/ethinyl estradiol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: