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

LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01499602

Enrollment

120

Registered

2011-12-26

Start date

2009-05-31

Completion date

2011-11-30

Last updated

2011-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Hyperplasia

Keywords

Endometrial hyperplasia,, LNG-IUS,, Progestin

Brief summary

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.

Interventions

DRUGLNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland

Initial release rate of 20µg Levonorgestrel per day for one year follow up.

DRUGNorethisterone Acetate tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.	At 3 and 6 months

Secondary

Measure	Time frame
Time to achieve complete regression	During the follow up period at 3,6,12 months after treatment

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026