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An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)

NCT00967746 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-08

No results posted yet for this study

Summary

This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception.

The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.

Conditions

  • Contraception

Interventions

DRUG

Etonogestrel-releasing IUS

Low dose; treatment duration of 6 months with a possible extension to 12 months

DRUG

Etonogestrel-releasing IUS

Intermediate dose; treatment duration of 6 months with a possible extension to 12 months

DRUG

Etonogestrel-releasing IUS

High dose; treatment duration of 6 months with a possible extension to 12 months

DEVICE

Multiload-cu 375®

Duration of 6 months with a possible extension to 12 months

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-11-30
Completion
2011-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00967746 on ClinicalTrials.gov