A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives

Teva Branded Pharmaceutical Products R&D, Inc.206 enrolled

Overview

This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

206

Conditions

Follicle Development Ovarian Follicle Follicle Count Follicle Size Oral Contraceptive

Interventions

Desogestrel/ethinyl estradiol and ethinyl estradiolDRUG

Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet

28-day drospirenone oral contraceptiveDRUG

Drospirenone/ethinyl estradiol 0.3/0.02 mg

28-day levonorgestrel oral contraceptiveDRUG

Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Premenopausal, non-pregnant, non-lactating women age 18-35 years old * Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m² * Regular spontaneous menstrual cycle * Others as dictated by Food and Drug Administration (FDA)-approved protocol Exclusion Criteria: * Any condition which contraindicates the use of combination oral contraceptives * Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders * Migraine headaches with focal, neurological symptoms * Others as dictated by FDA-approved protocol

Locations (2)

Teva Investigational Site 10119

Philadelphia, Pennsylvania, United States

Teva Investigational Site 10118

Seattle, Washington, United States

Outcomes

Primary Outcomes

Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.

Time frame: 16 weeks

Change in serum Estradiol level from baseline to week 16.

Time frame: 16 weeks

Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.

Time frame: 16 weeks

Change in serum Progesterone level from baseline to week 20.

Time frame: 20 weeks

Secondary Outcomes

Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.

Time frame: 15 weeks

Change from baseline to week 15 in D-dimer.

Time frame: 15 weeks

Change from baseline to end of week 15 in Plasmin-Antiplasmin complex

Time frame: 15 weeks

Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).

Time frame: 15 weeks

Change from baseline to week 15 in Fibrinogen.

Time frame: 15 weeks

Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.

Time frame: 15 weeks

Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).

Data from ClinicalTrials.gov

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