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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00117260
First Posted: July 6, 2005
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceutical Industries
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes 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
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
First Submitted: June 30, 2005
First Posted: July 6, 2005
Last Update Posted: August 12, 2013
Last Verified: August 2013

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