Clinical trial NCT00544882: A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021
Official title: A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Serum Estradiol Levels by Cycle Day
timeFrame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
measure: Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
timeFrame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
measure: Serum Inhibin-B Levels by Cycle Day
timeFrame: 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:
measure: Percentage of Follicles Greater Than 5 mm in Diameter
timeFrame: Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.
measure: Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size
timeFrame: Cycle 2, Days 1-20 and Cycle 2, Days 21-28
measure: Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
timeFrame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
measure: Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
timeFrame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
measure: Number of Days of Bleeding During Unscheduled and Scheduled Study Periods
timeFrame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
measure: Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
timeFrame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Other outcomes:
Locations:
city: Lawrenceville
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Seattle
country: United States
facility: Duramed Investigational Site
state: Washington
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References: