We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

HR-QoL and Sexuality in Mirena Inserted Contraception Users

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.
ClinicalTrials.gov Identifier: NCT00498784
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : January 23, 2013
Sponsor:
Information provided by:
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Drug: Mirena Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
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.
Study Start Date : November 2005
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Mirena
Mirena 52mg during 1 year



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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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

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 Posted: July 10, 2007    Key Record Dates
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