A Multicenter, Open-Label, Randomized, Controlled Study to Compare the Effects on Bone Mineral Density of DR-105 and a 28-Day Cycle Oral Contraceptive Regimen in Healthy, Postmenarchal, Adolescent Females
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duramed Research
- Enrollment
- 1,361
- Locations
- 46
- Primary Endpoint
- Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
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).
Intervention: 91-day Levonorgestrel Oral Contraceptive (Drug)
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).
Intervention: 28-day Levonorgestrel Oral Contraceptive (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)
Time Frame: 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 Outcomes
- Change From Baseline in Proximal Femur Bone Mineral Density(Baseline, Month 6 and Month 12)
- Change From Baseline in Lumbar Spine Bone Mineral Density(Baseline, Month 6 and Month 12)
- Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)(Baseline, Month 6 and Month 12)
- Change From Baseline in Total Body Bone Mineral Content (BMC)(Baseline, Month 6 and Month 12)
- 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)
- Change From Baseline in Proximal Femur Bone Mineral Content (BMC)(Baseline, Month 6 and Month 12)
- Change From Baseline in Total Body Bone Mineral Density(Baseline, Month 6 and Month 12)