Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

Mansoura University

Status: Completed

Conditions: Endometrial Hyperplasia

Treatments: Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland; Drug: Norethisterone Acetate tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT01499602

MU-324v

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of the Levonorgestrel releasing Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical endometrial hyperplasia in perimenopausal women.

Enrollment: 120 patients

Sex: Female

Ages: 40 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically confirmed simple or complex endometrial hyperplasia without atypia

Exclusion criteria

• Endometrial hyperplasia with atypia
• Other pathology e.g. patients with fibroids of any size, genital infection, adnexal abnormality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

LNG-IUS

Experimental group

Description:

Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up.

Treatment:

Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland

Norethisterone Acetate

Active Comparator group

Description:

Norethisterone Acetate tablets at a dose of 5 mg three times daily (15mg/day) for 3 weeks over three months.With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months

Treatment:

Drug: Norethisterone Acetate tablets