Status:
COMPLETED
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
Lead Sponsor:
Organon and Co
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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 health...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00967746
Start Date
November 1 2009
End Date
July 1 2011
Last Update
February 4 2022
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