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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01291004

Collaborator

(none)

206

Enrollment

Locations

Arms

Actual Duration (Months)

103

Patients Per Site

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Follicle Development Ovarian Follicle Follicle Count Follicle Size Oral Contraceptive	Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol Drug: 28-day drospirenone oral contraceptive Drug: 28-day levonorgestrel oral contraceptive	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins

Actual Study Start Date :

Jan 31, 2011

Actual Primary Completion Date :

Mar 31, 2012

Actual Study Completion Date :

Mar 31, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 28-day Desogestrel Oral Contraceptive	Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
Active Comparator: 28-day Drospirenone Oral Contraceptive	Drug: 28-day drospirenone oral contraceptive Drospirenone/ethinyl estradiol 0.3/0.02 mg
Active Comparator: 28-day Levonorgestrel Oral Contraceptive	Drug: 28-day levonorgestrel oral contraceptive Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

Arm

Intervention/Treatment

Experimental: 28-day Desogestrel Oral Contraceptive

Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol

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

Active Comparator: 28-day Drospirenone Oral Contraceptive

Drug: 28-day drospirenone oral contraceptive

Drospirenone/ethinyl estradiol 0.3/0.02 mg

Active Comparator: 28-day Levonorgestrel Oral Contraceptive

Drug: 28-day levonorgestrel oral contraceptive

Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

Outcome Measures

Primary Outcome Measures

Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. [16 weeks]
Change in serum Estradiol level from baseline to week 16. [16 weeks]
Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. [16 weeks]
Change in serum Progesterone level from baseline to week 20. [20 weeks]

Secondary Outcome Measures

Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [15 weeks]
Change from baseline to week 15 in D-dimer. [15 weeks]
Change from baseline to end of week 15 in Plasmin-Antiplasmin complex [15 weeks]
Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [15 weeks]
Change from baseline to week 15 in Fibrinogen. [15 weeks]
Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S. [15 weeks]
Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [15 weeks]
Change from baseline to week 15 in Antithrombin. [15 weeks]
Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [15 weeks]
Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [15 weeks]
Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [15 weeks]
Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [15 weeks]
Return to ovulation rate at week 20. [Week 20]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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