Clinical trial NCT00924560: A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Mineral Density
Keywords: Adolescents
Bone Mineral Density
Oral Contraceptive
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 1361
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Change From Baseline in Lumbar Spine Bone Mineral Density
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Proximal Femur Bone Mineral Density
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Proximal Femur Bone Mineral Content (BMC)
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Total Body Bone Mineral Density
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Total Body Bone Mineral Content (BMC)
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Bone-specific Alkaline Phosphatase
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Serum Deoxypyridinoline
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Serum Osteocalcin
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Serum Procollagen 1 N-terminal Propeptide
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Serum Type I Collagen N-telopeptide
timeFrame: Baseline, Month 6 and Month 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Investigational Site 007
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 018
state: Arizona
city: Tucson
country: United States
facility: Teva Investigational Site 005
state: Arizona
city: North Little Rock
country: United States
facility: Teva Investigational Site 047
state: Arkansas
city: La Mesa
country: United States
facility: Teva Investigational Site 027
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 040
state: California
city: Mountain View
country: United States
facility: Teva Investigational Site 037
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 013
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 017
state: California
city: Torrance
country: United States
facility: Teva Investigational Site 025
state: California
city: Washington
country: United States
facility: Teva Investigational Site 022
state: District of Columbia
city: Boynton Beach
country: United States
facility: Teva Investigational Site 004
state: Florida
city: Clearwater
country: United States
facility: Teva Investigational Site 008
state: Florida
city: DeLand
country: United States
facility: Teva Investigational Site 026
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 001
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 003
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 028
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site 041
state: Florida
city: Champaign
country: United States
facility: Teva Investigational Site 034
state: Illinois
city: Louisville
country: United States
facility: Teva Investigational Site 023
state: Kentucky
city: Baton Rouge
country: United States
facility: Teva Investigational Site 021
state: Louisiana
city: St. Louis
country: United States
facility: Teva Investigational Site 030
state: Missouri
city: Lincoln
country: United States
facility: Teva Investigational Site 009
state: Nebraska
city: Lawrenceville
country: United States
facility: Teva Investigational Site 010
state: New Jersey
city: Port Jefferson
country: United States
facility: Teva Investigational Site 038
state: New York
city: Rochester
country: United States
facility: Teva Investigational Site 048
state: New York
city: Durham
country: United States
facility: Teva Investigational Site 002
state: North Carolina
city: Kernersville
country: United States
facility: Teva Investigational Site 043
state: North Carolina
city: New Bern
country: United States
facility: Teva Investigational Site 044
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 020
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 006
state: North Carolina
city: Cleveland
country: United States
facility: Teva Investigational Site 033
state: Ohio
city: Medford
country: United States
facility: Teva Investigational Site 012
state: Oregon
city: Pittsburgh
country: United States
facility: Teva Investigational Site 035
state: Pennsylvania
city: Pottstown
country: United States
facility: Teva Investigational Site 039
state: Pennsylvania
city: Providence
country: United States
facility: Teva Investigational Site 036
state: Rhode Island
city: Charleston
country: United States
facility: Teva Investigational Site 032
state: South Carolina
city: Columbia
country: United States
facility: Teva Investigational Site 024
state: South Carolina
city: Dallas,
country: United States
facility: Teva Investigational Site 046
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 031
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 045
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 011
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 015
state: Utah
city: Norfolk
country: United States
facility: Teva Investigational Site 019
state: Virginia
city: Seattle
country: United States
facility: Teva Investigational Site 014
state: Washington
city: Spokane
country: United States
facility: Teva Investigational Site 016
state: Washington
Study officials:
affiliation: Teva GBP
name: Jen Henrick
role: STUDY_CHAIR
References: