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

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

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 Overview

• Status: Completed
• Conditions: Oral Contraceptive; Follicle Development; Ovarian Follicle; Follicle Count; Follicle Size
• Intervention / Treatment: Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol; Drug: 28-day drospirenone oral contraceptive; Drug: 28-day levonorgestrel oral contraceptive

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Teva Investigational Site 10119
  • Washington
    • Seattle, Washington, United States, 98105
      • Teva Investigational Site 10118

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Chair: Teva Women's Health Research Protocol Chair, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2011
• Primary Completion (Actual): March 31, 2012
• Study Completion (Actual): March 31, 2012

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Natriuretic Agents; Diuretics; Hormone Antagonists; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Progestins; Levonorgestrel; Estradiol; Contraceptive Agents; Ethinyl Estradiol; Contraceptives, Oral; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate; Drospirenone; Desogestrel
• Other Study ID Numbers: DSG-OI-101