Phase 2 N=1,361 Randomized Treatment

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

Bone Mineral Density

Bottom Line

View on ClinicalTrials.gov: NCT00924560 ↗

Enrolled (actual)

1,361

Serious AEs

1.7%

Results posted

Oct 2014

Primary outcome: Primary: Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD) — 2.26; 1.45; 2.50 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 91-day Levonorgestrel Oral Contraceptive (Drug); 28-day Levonorgestrel Oral Contraceptive (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: Female
Sponsor: Duramed Research
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)	2.26; 1.45; 2.50	—
SECONDARY Change From Baseline in Lumbar Spine Bone Mineral Density	0.02; 0.01; 0.01; 0.02; 0.01; 0.03	—
SECONDARY Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)	1.29; 0.69; 1.12; 1.86; 1.20; 1.94	—
SECONDARY Change From Baseline in Proximal Femur Bone Mineral Density	0.01; 0.00; 0.01; 0.02; 0.01; 0.01	—
SECONDARY Change From Baseline in Proximal Femur Bone Mineral Content (BMC)	0.26; 0.09; 0.13; 0.59; 0.28; 0.43	—
SECONDARY Change From Baseline in Total Body Bone Mineral Density	0.01; 0.01; 0.01; 0.01; 0.01; 0.02	—
SECONDARY Change From Baseline in Total Body Bone Mineral Content (BMC)	40.77; 38.70; 46.26; 72.86; 63.78; 84.95	—
SECONDARY Change From Baseline in Bone-specific Alkaline Phosphatase	-6.8; -5.9; -6.2; -6.9; -6.6; -10.3	—
SECONDARY Change From Baseline in Serum Deoxypyridinoline	-0.1; -0.1; 0.1; -0.1; 0.1; -0.1	—
SECONDARY Change From Baseline in Serum Osteocalcin	-4.8; -3.9; -5.1; -4.5; -3.7; -7.1	—
SECONDARY Change From Baseline in Serum Procollagen 1 N-terminal Propeptide	-49.9; -38.7; -57.8; -50.4; -39.8; -86.0	—
SECONDARY Change From Baseline in Serum Type I Collagen N-telopeptide	-4.8; -3.9; -0.7; -4.5; -4.3; -3.1	—
SECONDARY Number of Participants With Adverse Events (AEs)	252; 258; 274; 14; 20; 10	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00924560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.