A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hemostasis; Oral Contraceptive

Treatments: Drug: 28-day Desogestrel Oral Contraceptive; Drug: 28-day Levonorgestrel Oral Contraceptive; Drug: 91-day Levonorgestrel Oral Contraceptive

Study type: Interventional

Funder types: Industry

Identifiers

NCT01252186

PSE-HSP-203

2010-023215-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 265 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Premenopausal, non-pregnant, non-lactating women age 18-40 years old
• Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
• Regular spontaneous menstrual cycle
• Others as dictated by FDA-approved protocol

Exclusion criteria

• Any condition which contraindicates the use of combination oral contraceptives
• Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
• Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
• Others as dictated by FDA-approved protocol

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 3 patient groups

91-day Levonorgestrel Oral Contraceptive

Experimental group

Description:

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.

Treatment:

Drug: 91-day Levonorgestrel Oral Contraceptive

28-day Levonorgestrel Oral Contraceptive

Active Comparator group

Description:

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.

Treatment:

Drug: 28-day Levonorgestrel Oral Contraceptive

28-day Desogestrel Oral Contraceptive

Active Comparator group

Description:

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.

Treatment:

Drug: 28-day Desogestrel Oral Contraceptive