NCT00725413

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_4

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

4 years

First QC Date

July 28, 2008

Last Update Submit

February 2, 2022

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Acceptability (satisfaction questionnaire)

    Every 3 months, for the entire duration of the trial

Study Arms (1)

Arm 1

EXPERIMENTAL

Healthy premenopausal women requiring a long-term method of contraception

Drug: etonogestrel implant (Implanon)

Interventions

etonogestrel implant (Implanon)DRUG

subdermal etonogestrel implant

Also known as: Org 3236
Arm 1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Male
  • Postmenopause
  • Infertile
  • Under 18; Over 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

etonogestrel

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

November 1, 2001

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

February 4, 2022

Record last verified: 2022-02