Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device with a Follow-up of 3 Years.
Recruiting
N/A
Interventional Study
Contraception
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 48
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- University Hospital, Ghent · Other
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About This Trial
Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion, to assess uterine compatibility and the assurance of proper device placement. ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.
This multicentre, open-label…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Generally healthy women, 18 - 48 years of age and not having a contraindication for hysteroscopy
* Be willing to come back for the follow-ups
* Be willing to refrain from having intercourse the first two weeks and using tampons and menstrual cups in the first 2 months, followi…
Contacts