A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hemostasis; Oral Contraceptive

Treatments: Drug: desogestrel/ethinyl estradiol; Drug: desogestrel/ethinyl estradiol and ethinyl estradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01388491

DSG-HSP-201

Details and patient eligibility

About

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.

Enrollment: 293 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
• Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
• 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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293 participants in 2 patient groups

Treatment I: (DR-102)

Experimental group

Description:

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

Treatment:

Drug: desogestrel/ethinyl estradiol and ethinyl estradiol

Treatment II

Active Comparator group

Description:

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

Treatment:

Drug: desogestrel/ethinyl estradiol