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This study has been withdrawn prior to enrollment.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

Tracking Information
First Received Date ^ICMJE	June 30, 2005
Last Updated Date	January 8, 2010
Start Date ^ICMJE	July 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2005)	Mean percent change in the lumbar spine bone mineral density at month 12
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00117260 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 30, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Osteopenia
Intervention ^ICMJE	Drug: Seasonale (levonorgestrel and ethinyl estradiol)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	100
Completion Date	August 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	12 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00117260
Other Study ID Numbers ^ICMJE	SEA-305
Has Data Monitoring Committee	Not Provided
Responsible Party	Duramed Research, Inc
Study Sponsor ^ICMJE	Duramed Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Duramed Research
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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