Trial Condition(s):
Contraception
HR-QoL and sexuality in Mirena inserted contraception users
Bayer Identifier:
91458
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.
Inclusion Criteria
- Healthy woman willing to, or having to switch from her OC to another contraceptive method
Exclusion Criteria
- Any contraindication to Mirena insertion/use
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Bordeaux, France, 33076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multicenter, open labelled, uncontrolled, Phase IV clinical study to evaluate the Health-related Quality of life and sexual well-being in young (18-35) healthy Mirena users switching from OC, over the first year post-insertion.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Health-related QoL scoreTimeframe: 1 year
Secondary Outcome
- Sexuality Index, treatment satisfaction, usual safety outcomesTimeframe: 1 year
Additional Information
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