A Multicenter Study to Evaluate the Effects of DR-105 on Bone Mineral Density in Adolescent Females

Condition(s) targeted: Bone Mineral Density

Intervention: DR-105 (Drug); Lessina® (Drug); Control Group (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Duramed Research Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.

Overall contact:
Study Coordinator, Pharm.D., Phone: 215-293-7279, Email: medicalaffairs@barrlabs.com

This study is being conducted to compare the effects of DR-105 to a 28-day oral contraceptive regimen on bone mineral density (BMD) in adolescent females. Subjects will be randomized to either DR-105 or a 28-day oral contraceptive (OC). Subjects not seeking hormonal contraception who meet eligibility criteria will serve as a control group. Duration of the study for study subjects will be approximately 13 months.

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

Primary outcome: Mean percent change in lumbar spine BMD via dual energy x-ray absorptiometry (DXA) over a 12 month period

Secondary outcome:

Absolute change in lumbar spine, proximal femur, and total body BMD and bone mineral content (BMC) via DXA scan from baseline to month 6

Absolute change in the lumbar spine, proximal femur and total BMD, and BMC via DXA scan from baseline to month 12

Effects of biochemical markers of bone resorption and bone formation

Safety and tolerability of DR-105 in adolescent females

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

- BMI: 18 kg/m² to <30 kg/m², weight < 200 lbs

- Others as dictated by 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 Coordinator, Pharm.D., Phone: 215-293-7279, Email: medicalaffairs@barrlabs.com

Duramed Research Investigational Site, Phoenix, Arizona 85037, United States; Recruiting

Duramed Research Investigational Site, Phoenix, Arizona 85015, United States; Recruiting

Duramed Research Investigational Site, Tucson, Arizona 85712, United States; Recruiting

Duramed Research Investigational Site, La Mesa, California 91942, United States; Recruiting

Teva Investigational Site, Los Angeles, California 90036, United States; Recruiting

Duramed Research Investigational Site, San Diego, California 92103, United States; Recruiting

Duramed Research Investigational Site, San Diego, California 92123, United States; Recruiting

Duramed Research Investigational Site, Stanford, California 94305, United States; Recruiting

Duramed Research Investigational Site, Torrance, California 90502, United States; Recruiting

Duramed Research Investigational Site, Washington, District of Columbia 20036, United States; Active, not recruiting

Duramed Research Investigational Site, Boynton Beach, Florida 33472, United States; Recruiting

Duramed Research Investigational Site, Clearwater, Florida 33759, United States; Recruiting

Duramed Research Investigational Site, DeLand, Florida 32720, United States; Recruiting

Duramed Research Investigational Site, Miami, Florida 33143, United States; Recruiting

Duramed Research Investigational Site, Miami, Florida 33186, United States; Recruiting

Duramed Research Investigational Site, Tampa, Florida 33613, United States; Recruiting

Duramed Research Investigational Site, Champaign, Illinois 61820, United States; Recruiting

Duramed Research Investigational Site, Louisville, Kentucky 40202, United States; Recruiting

Duramed Research Investigational Site, Baton Rouge, Louisiana 70808, United States; Recruiting

Duramed Research Investigational Site, St. Louis, Missouri 63110, United States; Recruiting

Duramed Research Investigational Site, Lincoln, Nebraska 68510, United States; Recruiting

Duramed Research Investigational Site, Lawrenceville, New Jersey 08648, United States; Recruiting

Teva Investigational Site, Port Jefferson, New York 11777, United States; Recruiting

Duramed Research Investigational Site, Durham, North Carolina 27713, United States; Recruiting

Duramed Research Investigational Site, Raleigh, North Carolina 27612, United States; Recruiting

Duramed Research Investigational Site, Winston-Salem, North Carolina 27103, United States; Recruiting

Duramed Research Investigational Site, Cleveland, Ohio 44109, United States; Recruiting

Duramed Research Investigational Site, Medford, Oregon 97504, United States; Recruiting

Duramed Research Investigational Site, Pittsburgh, Pennsylvania 15213, United States; Recruiting

Teva Investigational Site, Pottstown, Pennsylvania 19464, United States; Recruiting

Duramed Research Investigational Site, Providence, Rhode Island 02903, United States; Recruiting

Duramed Research Investigational Site, Columbia, South Carolina 29201, United States; Recruiting

Duramed Research Investigational Site, Houston, Texas 77030, United States; Recruiting

Duramed Research Investigational Site, Waco, Texas 76712, United States; Recruiting

Duramed Research Investigational Site, Salt Lake City, Utah 84107, United States; Recruiting

Duramed Research Investigational Site, Virginia Beach, Virginia 23456, United States; Recruiting

Duramed Research Investigational Site, Seattle, Washington 98105, United States; Recruiting

Duramed Research Investigational Site, Spokane, Washington 99207, United States; Recruiting

Starting date: June 2009
Last updated: August 4, 2010