A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females
- Conditions
- Bone Mineral Density
- Interventions
- Registration Number
- NCT00924560
- Lead Sponsor
- Duramed Research
- 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 for each study participant will be approximately 13 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1361
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 91-day Levonorgestrel Oral Contraceptive 91-day Levonorgestrel Oral Contraceptive Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). 28-day Levonorgestrel Oral Contraceptive 28-day Levonorgestrel Oral Contraceptive Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
- Primary Outcome Measures
Name Time Method Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD) Baseline and Month 12 Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Percent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline \* 100%.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Proximal Femur Bone Mineral Density Baseline, Month 6 and Month 12 Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Change From Baseline in Lumbar Spine Bone Mineral Density Baseline, Month 6 and Month 12 Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Change From Baseline in Lumbar Spine Bone Mineral Content (BMC) Baseline, Month 6 and Month 12 Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Change From Baseline in Total Body Bone Mineral Content (BMC) Baseline, Month 6 and Month 12 Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Change From Baseline in Bone-specific Alkaline Phosphatase Baseline, Month 6 and Month 12 Change From Baseline in Serum Deoxypyridinoline Baseline, Month 6 and Month 12 Change From Baseline in Serum Osteocalcin Baseline, Month 6 and Month 12 Change From Baseline in Serum Procollagen 1 N-terminal Propeptide Baseline, Month 6 and Month 12 Change From Baseline in Serum Type I Collagen N-telopeptide Baseline, Month 6 and Month 12 Number of Participants With Adverse Events (AEs) 12 months An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.
A severe AE is defined as incapacitating, with inability to perform usual activities.
A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:
* fatal or life-threatening;
* required or prolonged inpatient hospitalization;
* resulted in persistent or significant disability/incapacity;
* congenital anomaly or birth defect;
* important medical event.Change From Baseline in Proximal Femur Bone Mineral Content (BMC) Baseline, Month 6 and Month 12 Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Change From Baseline in Total Body Bone Mineral Density Baseline, Month 6 and Month 12 Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Trial Locations
- Locations (46)
Teva Investigational Site 025
🇺🇸Torrance, California, United States
Teva Investigational Site 033
🇺🇸Cleveland, Ohio, United States
Teva Investigational Site 013
🇺🇸San Diego, California, United States
Teva Investigational Site 001
🇺🇸Miami, Florida, United States
Teva Investigational Site 031
🇺🇸Houston, Texas, United States
Teva Investigational Site 045
🇺🇸Houston, Texas, United States
Teva Investigational Site 041
🇺🇸West Palm Beach, Florida, United States
Teva Investigational Site 035
🇺🇸Pittsburgh, Pennsylvania, United States
Teva Investigational Site 014
🇺🇸Seattle, Washington, United States
Teva Investigational Site 019
🇺🇸Norfolk, Virginia, United States
Teva Investigational Site 016
🇺🇸Spokane, Washington, United States
Teva Investigational Site 002
🇺🇸Durham, North Carolina, United States
Teva Investigational Site 015
🇺🇸Salt Lake City, Utah, United States
Teva Investigational Site 030
🇺🇸St. Louis, Missouri, United States
Teva Investigational Site 018
🇺🇸Phoenix, Arizona, United States
Teva Investigational Site 046
🇺🇸Dallas,, Texas, United States
Teva Investigational Site 047
🇺🇸North Little Rock, Arkansas, United States
Teva Investigational Site 027
🇺🇸La Mesa, California, United States
Teva Investigational Site 026
🇺🇸DeLand, Florida, United States
Teva Investigational Site 043
🇺🇸Kernersville, North Carolina, United States
Teva Investigational Site 023
🇺🇸Louisville, Kentucky, United States
Teva Investigational Site 039
🇺🇸Pottstown, Pennsylvania, United States
Teva Investigational Site 034
🇺🇸Champaign, Illinois, United States
Teva Investigational Site 017
🇺🇸San Diego, California, United States
Teva Investigational Site 007
🇺🇸Phoenix, Arizona, United States
Teva Investigational Site 022
🇺🇸Washington, District of Columbia, United States
Teva Investigational Site 040
🇺🇸Los Angeles, California, United States
Teva Investigational Site 021
🇺🇸Baton Rouge, Louisiana, United States
Teva Investigational Site 020
🇺🇸Raleigh, North Carolina, United States
Teva Investigational Site 036
🇺🇸Providence, Rhode Island, United States
Teva Investigational Site 032
🇺🇸Charleston, South Carolina, United States
Teva Investigational Site 009
🇺🇸Lincoln, Nebraska, United States
Teva Investigational Site 012
🇺🇸Medford, Oregon, United States
Teva Investigational Site 024
🇺🇸Columbia, South Carolina, United States
Teva Investigational Site 010
🇺🇸Lawrenceville, New Jersey, United States
Teva Investigational Site 048
🇺🇸Rochester, New York, United States
Teva Investigational Site 011
🇺🇸Waco, Texas, United States
Teva Investigational Site 028
🇺🇸Tampa, Florida, United States
Teva Investigational Site 003
🇺🇸Miami, Florida, United States
Teva Investigational Site 005
🇺🇸Tucson, Arizona, United States
Teva Investigational Site 037
🇺🇸Mountain View, California, United States
Teva Investigational Site 044
🇺🇸New Bern, North Carolina, United States
Teva Investigational Site 006
🇺🇸Winston-Salem, North Carolina, United States
Teva Investigational Site 008
🇺🇸Clearwater, Florida, United States
Teva Investigational Site 004
🇺🇸Boynton Beach, Florida, United States
Teva Investigational Site 038
🇺🇸Port Jefferson, New York, United States