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HR-QoL and Sexuality in Mirena Inserted Contraception Users

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498784
First Posted: July 10, 2007
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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.

Condition Intervention Phase
Contraception Drug: Mirena Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Health-related QoL score [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Sexuality Index, treatment satisfaction, usual safety outcomes [ Time Frame: 1 year ]

Enrollment: 141
Study Start Date: November 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Mirena
Mirena 52mg during 1 year

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498784


Locations
France
Bordeaux, Gironde, France, 33076
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00498784     History of Changes
Other Study ID Numbers: 91458
2005-002955-42 ( EudraCT Number )
309663 ( Other Identifier: Company internal )
First Submitted: July 9, 2007
First Posted: July 10, 2007
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by Bayer:
Intra-uterine contraception
Intrauterine Devices

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral