Study to Evaluate the Safety and Efficacy of Seasonale fo... | NCT00117260

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

NCT00117260

Sponsor

Duramed Research

Status

Withdrawn

Last Update Posted

Aug 12, 2013Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Osteopenia

Interventions

Seasonale (levonorgestrel and ethinyl estradiol)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Not provided

Start Date

Jul 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Jun 30, 2005

First Submission Date that Met QC Criteria

Jun 30, 2005

First Posted Date

Jul 6, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2013

Last Update Posted Date

Aug 12, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Seasonale (levonorgestrel and ethinyl estradiol)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean percent change in the lumbar spine bone mineral density at month 12

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic
D000568	Amenorrhea

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C482584	Seasonale
D016912	Levonorgestrel
D004997	Ethinyl Estradiol

Ancestor Terms

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256

Browse Leaves

Not provided

Browse Branches

Not provided