Conditions: Hemostasis Oral Contraceptive
Keywords: Contraception Hemostasis Blood Coagulation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 265
Healthy volunteers: yes

Brief summary:
This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.

Detailed description:

Arms:
arm 1: Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. arm 2: Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. arm 3: Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.

Interventions: intervention 1: 91-day Levonorgestrel Oral Contraceptive intervention 2: 28-day Levonorgestrel Oral Contraceptive intervention 3: 28-day Desogestrel Oral Contraceptive
Intervention descriptions: intervention 1: 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE. intervention 2: 21 combination tablets containing 150 µg LNG/30 µg EE. intervention 3: 21 combination tablets containing 150 µg DSG/30 µg EE.

Protocol document: