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This study has been withdrawn prior to enrollment.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

History of Changes

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 3


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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals

Drug Information available for: Estradiol Ethinylestradiol Levonorgestrel

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

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


Enrollment:	0
Study Start Date:	July 2005
Study Completion Date:	August 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	12 Years to 17 Years (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Duramed Research, Inc
ClinicalTrials.gov Identifier:	NCT00117260 History of Changes
Other Study ID Numbers:	SEA-305
Study First Received:	June 30, 2005
Last Updated:	August 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:


osteopenia bone mineral density amenorrhea adolescents

Additional relevant MeSH terms:


Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Estradiol Ethinyl Estradiol Levonorgestrel Ethinyl estradiol, levonorgestrel drug combination Estrogens Hormones	Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on September 28, 2016

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