An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three E… (NCT00967746) | Clinical Trial Compass
CompletedPhase 2
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
Germany84 participantsStarted 2009-11
Plain-language 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®.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS