check_circleStudy Completed

Contraception

Bayer Identifier:

91458

ClinicalTrials.gov Identifier:

NCT00498784

EudraCT Number:

Not Available

EU CT Number:

Not Available
HR-QoL and sexuality in Mirena inserted contraception users

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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy woman willing to, or having to switch from her OC to another contraceptive method
  • - Any contraindication to Mirena insertion/use

Trial summary

Enrollment Goal
141
Trial Dates
November 2005 - October 2007
Phase
Phase 4
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bordeaux, 33076, France

Primary Outcome

  • Health-related QoL score
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    no

Secondary Outcome

  • Sexuality Index, treatment satisfaction, usual safety outcomes
    date_rangeTime Frame:
    1 year
    enhanced_encryption
    Safety Issue:
    yes

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

Additional Information

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