Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00117260

Enrollment

Registered

2005-07-06

Start date

2005-07-31

Completion date

2007-08-31

Last updated

2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia

Keywords

osteopenia, bone mineral density, amenorrhea, adolescents

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.

Interventions

DRUGSeasonale (levonorgestrel and ethinyl estradiol)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

12 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean percent change in the lumbar spine bone mineral density at month 12	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026