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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01291004
First received: February 4, 2011
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in serum Estradiol level from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in serum Progesterone level from baseline to week 20. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in D-dimer. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of week 15 in Plasmin-Antiplasmin complex [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in Fibrinogen. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in Antithrombin. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Return to ovulation rate at week 20. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291004

Locations
United States, Pennsylvania
Teva Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, Washington
Teva Investigational Site
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Chair: Teva Women's Health Research Protocol Chair Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01291004     History of Changes
Other Study ID Numbers: DSG-OI-101
Study First Received: February 4, 2011
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Desogestrel
Drospirenone
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Levonorgestrel
Polyestradiol phosphate
Cardiovascular Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Diuretics
Diuretics, Potassium Sparing
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014