A Study to Investigate the Contraceptive Efficacy and Saf... | NCT00725413

Studies
A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)

NCT00725413

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Feb 4, 2022Actual

Enrollment

210Actual

Phase

Phase 4

Conditions

Contraception

Interventions

etonogestrel implant (Implanon)

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

ID	Type	Description	Link
E-1729

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2001

Primary Completion Date

Nov 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Jul 28, 2008

First Submission Date that Met QC Criteria

Jul 29, 2008

First Posted Date

Jul 30, 2008Estimated

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

Feb 2, 2022

Last Update Posted Date

Feb 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various countries in order to obtain country-specific data.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Healthy premenopausal women requiring a long-term method of contraception	Drug: etonogestrel implant (Implanon)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
etonogestrel implant (Implanon)	Drug	subdermal etonogestrel implant	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy		Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.
(Serious) adverse events		Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.

Secondary Outcomes

Measure	Description	Time Frame
Acceptability (satisfaction questionnaire)		Every 3 months, for the entire duration of the trial

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible subjects are healthy premenopausal women requiring a long-term method of contraception, with a body mass index between 18 and 29 kg/m2, who are willing to give voluntary written informed consent. Subjects must have regular cycles with a usual length between 24 and 35 days.

Exclusion Criteria:

Male
Postmenopause
Infertile
Under 18; Over 40

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C044815	etonogestrel

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided