Status:
COMPLETED
A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females
Lead Sponsor:
Duramed Research
Conditions:
Bone Mineral Density
Eligibility:
FEMALE
12-18 years
Phase:
PHASE2
Brief Summary
This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a 28-day OC regimen on bone mineral density (BMD) in adolescent females.
Detailed Description
Participants will be randomized to either a 91-day OC or a 28-day OC. Participants not seeking hormonal contraception who meet eligibility criteria will serve as a control group. Duration of the study...
Eligibility Criteria
Inclusion
- Healthy postmenarchal adolescent female 12-18 years old, non-pregnant, nonlactating
- Regular spontaneous menstrual cycles
- Body mass index (BMI): 18 kg/m² to \<30 kg/m², weight \< 200 lbs
- Others as dictated by the Food and Drug Administration (FDA)-approved protocol
Exclusion
- Any contraindication to the use of oral contraceptives
- History of previous clinically significant adverse event while taking hormonal contraceptives
- Use of any medication which could significantly interfere with study assessments
- Others as dictated by FDA-approved protocol
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1361 Patients enrolled
Trial Details
Trial ID
NCT00924560
Start Date
June 1 2009
End Date
August 1 2012
Last Update
October 22 2014
Active Locations (46)
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1
Teva Investigational Site 007
Phoenix, Arizona, United States
2
Teva Investigational Site 018
Phoenix, Arizona, United States
3
Teva Investigational Site 005
Tucson, Arizona, United States
4
Teva Investigational Site 047
North Little Rock, Arkansas, United States