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This study has been withdrawn prior to enrollment.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

June 30, 2005
August 8, 2013
July 2005
July 2007   (final data collection date for primary outcome measure)
Mean percent change in the lumbar spine bone mineral density at month 12
Same as current
Complete list of historical versions of study NCT00117260 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteopenia
Drug: Seasonale (levonorgestrel and ethinyl estradiol)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2007
July 2007   (final data collection date for primary outcome measure)

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
Female
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00117260
SEA-305
Not Provided
Duramed Research, Inc
Duramed Research
Not Provided
Not Provided
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP