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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bone Mineral Density

Intervention: 91-day Levonorgestrel Oral Contraceptive (Drug); 28-day Levonorgestrel Oral Contraceptive (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Jen Henrick, Study Chair, Affiliation: Teva GBP

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.

Clinical Details

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

Primary outcome: Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)

Secondary outcome:

Change From Baseline in Lumbar Spine Bone Mineral Density

Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)

Change From Baseline in Proximal Femur Bone Mineral Density

Change From Baseline in Proximal Femur Bone Mineral Content (BMC)

Change From Baseline in Total Body Bone Mineral Density

Change From Baseline in Total Body Bone Mineral Content (BMC)

Change From Baseline in Bone-specific Alkaline Phosphatase

Change From Baseline in Serum Deoxypyridinoline

Change From Baseline in Serum Osteocalcin

Change From Baseline in Serum Procollagen 1 N-terminal Propeptide

Change From Baseline in Serum Type I Collagen N-telopeptide

Number of Participants With Adverse Events (AEs)

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

Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): Female.

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

Locations and Contacts

Teva Investigational Site 007, Phoenix, Arizona, United States

Teva Investigational Site 018, Phoenix, Arizona, United States

Teva Investigational Site 005, Tucson, Arizona, United States

Teva Investigational Site 047, North Little Rock, Arkansas, United States

Teva Investigational Site 027, La Mesa, California, United States

Teva Investigational Site 040, Los Angeles, California, United States

Teva Investigational Site 037, Mountain View, California, United States

Teva Investigational Site 013, San Diego, California, United States

Teva Investigational Site 017, San Diego, California, United States

Teva Investigational Site 025, Torrance, California, United States

Teva Investigational Site 022, Washington, District of Columbia, United States

Teva Investigational Site 004, Boynton Beach, Florida, United States

Teva Investigational Site 008, Clearwater, Florida, United States

Teva Investigational Site 026, DeLand, Florida, United States

Teva Investigational Site 001, Miami, Florida, United States

Teva Investigational Site 003, Miami, Florida, United States

Teva Investigational Site 028, Tampa, Florida, United States

Teva Investigational Site 041, West Palm Beach, Florida, United States

Teva Investigational Site 034, Champaign, Illinois, United States

Teva Investigational Site 023, Louisville, Kentucky, United States

Teva Investigational Site 021, Baton Rouge, Louisiana, United States

Teva Investigational Site 030, St. Louis, Missouri, United States

Teva Investigational Site 009, Lincoln, Nebraska, United States

Teva Investigational Site 010, Lawrenceville, New Jersey, United States

Teva Investigational Site 038, Port Jefferson, New York, United States

Teva Investigational Site 048, Rochester, New York, United States

Teva Investigational Site 002, Durham, North Carolina, United States

Teva Investigational Site 043, Kernersville, North Carolina, United States

Teva Investigational Site 044, New Bern, North Carolina, United States

Teva Investigational Site 020, Raleigh, North Carolina, United States

Teva Investigational Site 006, Winston-Salem, North Carolina, United States

Teva Investigational Site 033, Cleveland, Ohio, United States

Teva Investigational Site 012, Medford, Oregon, United States

Teva Investigational Site 035, Pittsburgh, Pennsylvania, United States

Teva Investigational Site 039, Pottstown, Pennsylvania, United States

Teva Investigational Site 036, Providence, Rhode Island, United States

Teva Investigational Site 032, Charleston, South Carolina, United States

Teva Investigational Site 024, Columbia, South Carolina, United States

Teva Investigational Site 046, Dallas,, Texas, United States

Teva Investigational Site 031, Houston, Texas, United States

Teva Investigational Site 045, Houston, Texas, United States

Teva Investigational Site 011, Waco, Texas, United States

Teva Investigational Site 015, Salt Lake City, Utah, United States

Teva Investigational Site 019, Norfolk, Virginia, United States

Teva Investigational Site 014, Seattle, Washington, United States

Teva Investigational Site 016, Spokane, Washington, United States

Additional Information

Starting date: June 2009
Last updated: October 10, 2014

Page last updated: August 23, 2015

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