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

Osteopenia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00117260
• Other study ID #: SEA-305
• Status: Withdrawn
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: August 8, 2013
• Start date: July 2005
• Est. completion date: August 2007

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia

Intervention

Drug:
• Seasonale (levonorgestrel and ethinyl estradiol)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change in the lumbar spine bone mineral density at month 12
Secondary	Interim and 24 month mean percent change in lumbar spine bone mineral density
Secondary	Mean percent change in the proximal femur (hip) bone mineral density
Secondary	Mean percent change in total body bone mineral density
Secondary	Mean change in biochemical markers of bone resorption and bone formation
Secondary	Change in body weight