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

Phase 2

Completed

• Conditions: Contraception
• Interventions: Device: Multiload-cu 375®; Drug: Etonogestrel-releasing IUS

• Registration Number: NCT00967746
• Lead Sponsor: Organon and Co

Brief 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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Study Start: 2009-11
• Primary Completion: 2010-11
• Study Completion: 2011-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiload	Multiload-cu 375®	Multiload-cu 375®
ENG-MIUS intermediate	Etonogestrel-releasing IUS	Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm
ENG-MIUS high	Etonogestrel-releasing IUS	High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm
ENG-MIUS low	Etonogestrel-releasing IUS	Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Vaginal bleeding pattern	Days 92 to 182