- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00117260
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
August 8, 2013 updated by: Duramed Research
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Mean percent change in the lumbar spine bone mineral density at month 12
|
Secondary Outcome Measures
Outcome Measure |
---|
Change in body weight
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
June 30, 2005
First Submitted That Met QC Criteria
June 30, 2005
First Posted (Estimate)
July 6, 2005
Study Record Updates
Last Update Posted (Estimate)
August 12, 2013
Last Update Submitted That Met QC Criteria
August 8, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Levonorgestrel
- Estradiol
- Ethinyl Estradiol
- Ethinyl estradiol, levonorgestrel drug combination
Other Study ID Numbers
- SEA-305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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