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

NCT00544882 | Completed Phase 3 Results

• 1 other identifier: DR-DSG-302
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Serum Estradiol Levels by Cycle Day

  Levels of estradiol were measured throughout the study from blood samples.

  Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.

• Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day

  Levels of follicle stimulating hormone were measured throughout the study from blood samples.

  Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.

• Serum Inhibin-B Levels by Cycle Day

  Levels of inhibin-B were measured throughout the study from blood samples.

  Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.

Secondary Outcomes (6)

• Percentage of Follicles Greater Than 5 mm in Diameter

  Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.

• Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size

  Cycle 2, Days 1-20 and Cycle 2, Days 21-28

• Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods

  Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

• Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods

  Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

• Number of Days of Bleeding During Unscheduled and Scheduled Study Periods

  Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

Study Arms (2)

DR-1021

EXPERIMENTAL

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; Drug: Kariva®

Mircette

ACTIVE COMPARATOR

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®; Drug: Kariva®

Interventions

DR-1021 DRUG

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.

Also known as: desogestrel/ethinyl estradiol

DR-1021

Mircette® DRUG

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Also known as: desogestrel/ethinyl estradiol

Mircette

Kariva® DRUG

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Also known as: desogestrel/ethinyl estradiol

DR-1021; Mircette

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (4)

Duramed Investigational Site

Lawrenceville, New Jersey, 08648, United States

Location

Duramed Investigational Site

Columbus, Ohio, 43213, United States

Location

Duramed Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

Duramed Investigational Site

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

Desogestrel; Oviol

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D

clinicaltrialsdisclosure@tevapharm.com

610-786-7047

Study Officials

• Duramed Protocol Chair

  Duramed Research, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2007
• First Posted: October 16, 2007
• Study Start: October 31, 2007
• Primary Completion: March 31, 2008
• Study Completion: March 31, 2008
• Last Updated: November 18, 2021
• Results First Posted: June 10, 2014

Record last verified: 2021-11

Locations

US (4)