NCT00117260

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2005

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

2 years

First QC Date

June 30, 2005

Last Update Submit

August 8, 2013

Conditions

Osteopenia

Keywords

osteopeniabone mineral densityamenorrheaadolescents

Outcome Measures

Primary Outcomes (1)

  • Mean percent change in the lumbar spine bone mineral density at month 12

Secondary Outcomes (5)

  • 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

Interventions

Seasonale (levonorgestrel and ethinyl estradiol)DRUG

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Undiagnosed abnormal genital bleeding
  • Known or suspected pregnancy
  • Medical history of any disorder that contraindicates the use of oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Diseases, MetabolicAmenorrhea

Interventions

SeasonaleLevonorgestrelEthinyl Estradiol

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 6, 2005

Study Start

July 1, 2005

Primary Completion

July 1, 2007

Study Completion

August 1, 2007

Last Updated

August 12, 2013

Record last verified: 2013-08