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

Organon

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: Etonogestrel-releasing IUS; Device: Multiload-cu 375®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00967746

P06060

Details and patient eligibility

About

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®.

Enrollment: 84 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

84 participants in 4 patient groups

ENG-MIUS low

Experimental group

Description:

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

Treatment:

Drug: Etonogestrel-releasing IUS

ENG-MIUS intermediate

Experimental group

Description:

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

Treatment:

Drug: Etonogestrel-releasing IUS

ENG-MIUS high

Experimental group

Description:

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

Treatment:

Drug: Etonogestrel-releasing IUS

Multiload

Active Comparator group

Description:

Multiload-cu 375®

Treatment:

Device: Multiload-cu 375®