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

February 2, 2022 updated by: Organon and Co

A Randomized, Multicenter, Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Doses of an Etonogestrel-releasing Medicated Intrauterine System (ENG-MIUS) Versus a Copper-releasing Intrauterine Device (IUD)

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy female subjects in need for contraception will be selected to participate in the trial;
  • Each subject must be >=18 to <=40 years of age at screening and in need for contraception;
  • Each subject must have given birth to at least one child (gestational age >=28 weeks);
  • Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri.

Exclusion Criteria:

  • A subject must not be pregnant or suspected to be pregnant;
  • A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis;
  • A subject must not have a history or presence of any malignancy;
  • A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies;
  • A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);
  • A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of >=3 times the upper normal limit;
  • A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;
  • A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator;
  • A subject must not have vaginal bleeding of undiagnosed etiology;
  • A subject must not have dysmenorrhea interfering with daily activities or menorrhagia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENG-MIUS low
Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm
Drug: Etonogestrel-releasing IUS
Low dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Drug: Etonogestrel-releasing IUS
Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Drug: Etonogestrel-releasing IUS
High dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Experimental: ENG-MIUS intermediate
Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm
Drug: Etonogestrel-releasing IUS
Low dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Drug: Etonogestrel-releasing IUS
Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Drug: Etonogestrel-releasing IUS
High dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Experimental: ENG-MIUS high
High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm
Drug: Etonogestrel-releasing IUS
Low dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Drug: Etonogestrel-releasing IUS
Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Drug: Etonogestrel-releasing IUS
High dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
  • SCH 900342
  • ORG 299001
Active Comparator: Multiload
Multiload-cu 375®
Device: Multiload-cu 375®
Duration of 6 months with a possible extension to 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Vaginal bleeding pattern
Time Frame: Days 92 to 182
Days 92 to 182

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (Estimate)

August 28, 2009

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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