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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bone Mineral Density

Intervention / Treatment
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* Drug: 91-day Levonorgestrel Oral Contraceptive
* Drug: 28-day Levonorgestrel Oral Contraceptive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 91-day Levonorgestrel Oral Contraceptive<br>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). | Drug: 91-day Levonorgestrel Oral Contraceptive<br>* Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet. Take 1 tablet daily<br>* Other names: Seasonique®;|
| Active Comparator: 28-day Levonorgestrel Oral Contraceptive<br>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). | Drug: 28-day Levonorgestrel Oral Contraceptive<br>* Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily<br>* Other names: Lessina®;|
| No Intervention: Untreated Control<br>Participants received no oral contraceptives during the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD) | 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%. | Baseline and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Lumbar Spine Bone Mineral Density | Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. | Baseline, Month 6 and Month 12 | 
| Change From Baseline in Lumbar Spine Bone Mineral Content (BMC) | Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. | Baseline, Month 6 and Month 12 | 
| Change From Baseline in Proximal Femur Bone Mineral Density | Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. | Baseline, Month 6 and Month 12 | 
| Change From Baseline in Proximal Femur Bone Mineral Content (BMC) | Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. | Baseline, Month 6 and Month 12 | 
| Change From Baseline in Total Body Bone Mineral Density | Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. | Baseline, Month 6 and Month 12 | 
| Change From Baseline in Total Body Bone Mineral Content (BMC) | Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. | 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) | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Bone Mineral Density, Oral Contraceptive