A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females

Completed · Phase 2 · Has a placebo group

Conditions studied: Bone Mineral Density

In brief

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.

Key facts

Study ID

NCT00924560

Run by

Duramed Research

People needed

1361

Starts

2009-06-01

Expected to finish

2012-08-01

Last updated by the study team

2014-10-22

Who can join

Age: 12 and older, up to 18. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Teva Investigational Site 007 — Phoenix, Arizona, United States
• Teva Investigational Site 018 — Phoenix, Arizona, United States
• Teva Investigational Site 005 — Tucson, Arizona, United States
• Teva Investigational Site 047 — North Little Rock, Arkansas, United States
• Teva Investigational Site 027 — La Mesa, California, United States
• Teva Investigational Site 040 — Los Angeles, California, United States
• Teva Investigational Site 037 — Mountain View, California, United States
• Teva Investigational Site 013 — San Diego, California, United States
• Teva Investigational Site 017 — San Diego, California, United States
• Teva Investigational Site 025 — Torrance, California, United States
• Teva Investigational Site 022 — Washington D.C., District of Columbia, United States
• Teva Investigational Site 004 — Boynton Beach, Florida, United States
• Teva Investigational Site 008 — Clearwater, Florida, United States
• Teva Investigational Site 026 — DeLand, Florida, United States
• Teva Investigational Site 001 — Miami, Florida, United States
• Teva Investigational Site 003 — Miami, Florida, United States
• Teva Investigational Site 028 — Tampa, Florida, United States
• Teva Investigational Site 041 — West Palm Beach, Florida, United States
• Teva Investigational Site 034 — Champaign, Illinois, United States
• Teva Investigational Site 023 — Louisville, Kentucky, United States
• Teva Investigational Site 021 — Baton Rouge, Louisiana, United States
• Teva Investigational Site 030 — St Louis, Missouri, United States
• Teva Investigational Site 009 — Lincoln, Nebraska, United States
• Teva Investigational Site 010 — Lawrenceville, New Jersey, United States
• Teva Investigational Site 038 — Port Jefferson, New York, United States

Full record on ClinicalTrials.gov

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