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

Contraception Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967746
• Other study ID #: P06060
• Status: Completed
• Phase: Phase 2
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Uterine Hemorrhage

Intervention

Drug:
• Etonogestrel-releasing IUS
Low dose; treatment duration of 6 months with a possible extension to 12 months
• Etonogestrel-releasing IUS
Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vaginal bleeding pattern		Days 92 to 182