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Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density

This study has been withdrawn prior to enrollment.
(Sponsor decision)
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00117260
First received: June 30, 2005
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  Purpose

This is a randomized, multicenter, placebo-controlled study to evaluate the effects of Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had their menstrual period but now have secondary amenorrhea and also have osteopenia. The duration of the study for each patient will be approximately two years.


Condition Intervention Phase
Osteopenia
 Drug: Seasonale (levonorgestrel and ethinyl estradiol)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a 91-Day Extended-Cycle Combination Oral Contraceptive (Seasonale) for the Treatment of Low Bone Mineral Density in Adolescent Females With Secondary Amenorrhea and Osteopenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Mean percent change in the lumbar spine bone mineral density at month 12

Secondary Outcome Measures:
  • Interim and 24 month mean percent change in lumbar spine bone mineral density
  • Mean percent change in the proximal femur (hip) bone mineral density
  • Mean percent change in total body bone mineral density
  • Mean change in biochemical markers of bone resorption and bone formation
  • Change in body weight

Estimated Enrollment: 100
Study Start Date: July 2005
Estimated Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Not sexually active and agree to remain sexually inactive throughout the course of the study
  • First menstrual period at least one year ago
  • No menstrual period in the last 6 months

Exclusion Criteria:

  • Undiagnosed abnormal genital bleeding
  • Known or suspected pregnancy
  • Medical history of any disorder that contraindicates the use of oral contraceptives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117260

Locations
United States, Kentucky
Duramed Investigational Site
Louisville, Kentucky, United States, 40492
United States, Ohio
Duramed Investigational Site
Cleveland, Ohio, United States, 44109
United States, Rhode Island
Duramed Investigational Site
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Duramed Research
  More Information

No publications provided

Responsible Party: Duramed Research, Inc
ClinicalTrials.gov Identifier: NCT00117260     History of Changes
Other Study ID Numbers: SEA-305
Study First Received: June 30, 2005
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duramed Research:
osteopenia
bone mineral density
amenorrhea
adolescents

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Contraceptives, Oral
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estradiol
Ethinyl Estradiol
Contraceptive Agents, Female
Contraceptive Agents
 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 May 23, 2013