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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This study has been withdrawn prior to enrollment.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:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00117260
First received: June 30, 2005
Last updated: August 8, 2013
Last verified: August 2013
  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:


Further study details as provided by Teva Pharmaceutical Industries:

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

Enrollment: 0
Study Start Date: July 2005
Study Completion Date: August 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  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
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.

No Contacts or Locations Provided
  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: August 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
osteopenia
bone mineral density
amenorrhea
adolescents

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

ClinicalTrials.gov processed this record on November 24, 2014