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

NCT00967746 | Completed Phase 2

• 1 other identifier: P06060
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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®.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vaginal bleeding pattern

  Days 92 to 182

Study Arms (4)

ENG-MIUS low

EXPERIMENTAL

Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm

Drug: Etonogestrel-releasing IUS

ENG-MIUS intermediate

EXPERIMENTAL

Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm

Drug: Etonogestrel-releasing IUS

ENG-MIUS high

EXPERIMENTAL

High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm

Drug: Etonogestrel-releasing IUS

Multiload

ACTIVE COMPARATOR

Multiload-cu 375®

Device: Multiload-cu 375®

Interventions

Etonogestrel-releasing IUS DRUG

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

Also known as: SCH 900342, ORG 299001

ENG-MIUS low

Multiload-cu 375® DEVICE

Duration of 6 months with a possible extension to 12 months

Multiload

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (1)

Dinox GmbH

Berlin, D-10115, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2011
• Last Updated: April 8, 2026

Record last verified: 2022-02

Locations

DE (1)