Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density - Full Text View

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00117260

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 III

MedlinePlus related topics: Minerals

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Ethinyl estradiol Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Duramed Research:

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

Estimated Enrollment:	100
Study Start Date:	July 2005
Estimated Study Completion Date:	August 2007

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117260

Locations

United States, Kentucky
Duramed Investigational Site
Louisville, Kentucky, United States, 40492
United States, Ohio
Duramed Investigational Site
Cleveland, Ohio, United States, 44109
United States, Rhode Island
Duramed Investigational Site
Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

Duramed Research

More Information

Study ID Numbers:	SEA-305
Study First Received:	June 30, 2005
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00117260
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

osteopenia
bone mineral density
amenorrhea
adolescents

Study placed in the following topic categories:

Musculoskeletal Diseases
Levonorgestrel
Estradiol 3-benzoate
Estradiol valerate
Amenorrhea
Neoplasm Metastasis

Ethinyl Estradiol
Bone Diseases, Metabolic
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Bone Diseases
Estradiol

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009