Trial record 6 of 224 for:    (adolescence OR teen) AND female NOT (male OR men)

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00924560
First received: June 18, 2009
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Bone Mineral Density
Drug: Seasonique
Drug: Lessina®
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Mean percent change in lumbar spine BMD via dual energy x-ray absorptiometry (DXA) over a 12 month period [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in lumbar spine, proximal femur, and total body BMD and bone mineral content (BMC) via DXA scan from baseline to month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Absolute change in the lumbar spine, proximal femur and total BMD, and BMC via DXA scan from baseline to month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effects of biochemical markers of bone resorption and bone formation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of DR-105 in adolescent females [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 1363
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DR-105, Seasonique
Drug: Seasonique

Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.

Take 1 tablet daily

Other Names:
  • levonorgestrel/ethinyl estradiol
  • DR-105
Active Comparator: 2
28-day OC
Drug: Lessina®
Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
Other Name: levonorgestrel/ethinyl estradiol

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924560

  Show 46 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Jen Henrick Teva GBP
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00924560     History of Changes
Other Study ID Numbers: DR-105-202
Study First Received: June 18, 2009
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Adolescents
Bone Mineral Density
Oral Contraceptive

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on August 21, 2014