A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT00544882
First received: October 12, 2007
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.


Condition Intervention Phase
Healthy
Drug: DR-1021
Drug: Mircette®
Drug: Kariva®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Serum Estradiol Levels by Cycle Day [ Time Frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. ] [ Designated as safety issue: No ]
    Levels of estradiol were measured throughout the study from blood samples.

  • Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day [ Time Frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. ] [ Designated as safety issue: No ]
    Levels of follicle stimulating hormone were measured throughout the study from blood samples.

  • Serum Inhibin-B Levels by Cycle Day [ Time Frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. ] [ Designated as safety issue: No ]
    Levels of inhibin-B were measured throughout the study from blood samples.


Secondary Outcome Measures:
  • Percentage of Follicles Greater Than 5 mm in Diameter [ Time Frame: Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4. ] [ Designated as safety issue: No ]
    Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).

  • Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size [ Time Frame: Cycle 2, Days 1-20 and Cycle 2, Days 21-28 ] [ Designated as safety issue: No ]
    The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.

  • Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods [ Time Frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 ] [ Designated as safety issue: No ]
    The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.

  • Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods [ Time Frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 ] [ Designated as safety issue: No ]
    The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.

  • Number of Days of Bleeding During Unscheduled and Scheduled Study Periods [ Time Frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 ] [ Designated as safety issue: No ]
    The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.

  • Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods [ Time Frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 ] [ Designated as safety issue: No ]
    The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.


Enrollment: 61
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DR-1021
After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
Drug: DR-1021
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
Other Name: desogestrel/ethinyl estradiol
Drug: Kariva®
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Other Name: desogestrel/ethinyl estradiol
Active Comparator: Mircette
After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
Drug: Mircette®
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Other Name: desogestrel/ethinyl estradiol
Drug: Kariva®
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Other Name: desogestrel/ethinyl estradiol

Detailed Description:

Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior to beginning the Cycle 1 baseline cycle. After completing screening, all enrolled participants continued to receive the same regimen of 150 μg DSG /20 μg EE combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1 (the Run-In phase). Following completion of Cycle 1, participants were randomly assigned to receive either DR-1021 or Mircette during Cycle 2. All participants who completed Cycle 2 were to receive Kariva during Cycle 3; however, participants were only followed for the first 21 days of this 28-day regimen, after which they were considered study completers.

  Eligibility

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

Inclusion Criteria:

  • Premenopausal
  • Weight <200 lbs
  • Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1
  • Others as dictated by protocol

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  • Breast feeding
  • Smoking > 10 cigarettes per day
  • Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])
  • Others as dictated by 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: NCT00544882

Locations
United States, New Jersey
Duramed Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, Ohio
Duramed Investigational Site
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Duramed Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, Washington
Duramed Investigational Site
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00544882     History of Changes
Other Study ID Numbers: DR-DSG-302
Study First Received: October 12, 2007
Results First Received: May 8, 2014
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014