HR-QoL and Sexuality in Mirena Inserted Contraception Users

Bayer

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Drug: Mirena

Study type: Interventional

Funder types: Industry

Identifiers

NCT00498784

91458

309663 (Other Identifier)

2005-002955-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Mirena