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

Bone Mineral Density Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924560
• Other study ID #: DR-105-202
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2009
• Last updated: October 10, 2014
• Start date: June 2009
• Est. completion date: August 2012

Study information

• Verified date: October 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1361
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Mineral Density

Intervention

Drug:
• 91-day Levonorgestrel Oral Contraceptive
Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet. Take 1 tablet daily
• 28-day Levonorgestrel Oral Contraceptive
Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily

Locations

Country	Name	City	State
United States	Teva Investigational Site 021	Baton Rouge	Louisiana
United States	Teva Investigational Site 004	Boynton Beach	Florida
United States	Teva Investigational Site 034	Champaign	Illinois
United States	Teva Investigational Site 032	Charleston	South Carolina
United States	Teva Investigational Site 008	Clearwater	Florida
United States	Teva Investigational Site 033	Cleveland	Ohio
United States	Teva Investigational Site 024	Columbia	South Carolina
United States	Teva Investigational Site 046	Dallas,	Texas
United States	Teva Investigational Site 026	DeLand	Florida
United States	Teva Investigational Site 002	Durham	North Carolina
United States	Teva Investigational Site 031	Houston	Texas
United States	Teva Investigational Site 045	Houston	Texas
United States	Teva Investigational Site 043	Kernersville	North Carolina
United States	Teva Investigational Site 027	La Mesa	California
United States	Teva Investigational Site 010	Lawrenceville	New Jersey
United States	Teva Investigational Site 009	Lincoln	Nebraska
United States	Teva Investigational Site 040	Los Angeles	California
United States	Teva Investigational Site 023	Louisville	Kentucky
United States	Teva Investigational Site 012	Medford	Oregon
United States	Teva Investigational Site 001	Miami	Florida
United States	Teva Investigational Site 003	Miami	Florida
United States	Teva Investigational Site 037	Mountain View	California
United States	Teva Investigational Site 044	New Bern	North Carolina
United States	Teva Investigational Site 019	Norfolk	Virginia
United States	Teva Investigational Site 047	North Little Rock	Arkansas
United States	Teva Investigational Site 007	Phoenix	Arizona
United States	Teva Investigational Site 018	Phoenix	Arizona
United States	Teva Investigational Site 035	Pittsburgh	Pennsylvania
United States	Teva Investigational Site 038	Port Jefferson	New York
United States	Teva Investigational Site 039	Pottstown	Pennsylvania
United States	Teva Investigational Site 036	Providence	Rhode Island
United States	Teva Investigational Site 020	Raleigh	North Carolina
United States	Teva Investigational Site 048	Rochester	New York
United States	Teva Investigational Site 015	Salt Lake City	Utah
United States	Teva Investigational Site 013	San Diego	California
United States	Teva Investigational Site 017	San Diego	California
United States	Teva Investigational Site 014	Seattle	Washington
United States	Teva Investigational Site 016	Spokane	Washington
United States	Teva Investigational Site 030	St. Louis	Missouri
United States	Teva Investigational Site 028	Tampa	Florida
United States	Teva Investigational Site 025	Torrance	California
United States	Teva Investigational Site 005	Tucson	Arizona
United States	Teva Investigational Site 011	Waco	Texas
United States	Teva Investigational Site 022	Washington	District of Columbia
United States	Teva Investigational Site 041	West Palm Beach	Florida
United States	Teva Investigational Site 006	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change From Baseline in Bone-specific Alkaline Phosphatase		Baseline, Month 6 and Month 12	No
Secondary	Change From Baseline in Serum Deoxypyridinoline		Baseline, Month 6 and Month 12	No
Secondary	Change From Baseline in Serum Osteocalcin		Baseline, Month 6 and Month 12	No
Secondary	Change From Baseline in Serum Procollagen 1 N-terminal Propeptide		Baseline, Month 6 and Month 12	No
Secondary	Change From Baseline in Serum Type I Collagen N-telopeptide		Baseline, Month 6 and Month 12	No
Secondary	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	Yes