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Comparing the Administration of Letrozole and Megestrol Acetate in the Treatment of Women with Simple Endometrial Hyperplasia without Atypia: A Randomized Clinical Trial

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Abstract

Introduction

The present study was conducted as a pilot to compare the therapeutic effects and the potential side effects of oral Megestrol acetate and Letrozole in the treatment of simple hyperplasia in perimenopausal women.

Methods

The participants of this randomized clinical trial consisted of two groups of 25 women aged 44–50 presenting with abnormal uterine bleeding diagnosed with simple endometrial hyperplasia without cytologic atypia confirmed by transvaginal ultrasonography and biopsy. The first group received 40-mg doses of Megestrol acetate for 2 weeks per month for a total period of 2 months. The second group received 2.5-mg daily doses of Letrozole for a total period of 2 months. The differences in terms of quantitative measurements were analyzed using the independent two-sample t test and the paired t test. To compare the two groups in terms of the distribution of the categorical variables, Pearson’s Chi square and Fisher’s Exact tests were used at the significance level of 0.05 by Stata-9.2.

Results

Although the intervention led to significant improvements in both groups (P < .001), there was no difference between the groups in terms of accomplishing resolution (P = .74) [seven (28%) patients in the Letrozole group and five (20%) in the Megestrol group], while two patients in the Letrozole group and nine in the Megestrol group suffered from side effects, suggesting significantly lower side effects in the Letrozole group (P = .02).

Conclusion

Letrozole and Megestrol acetate seem to have similar effects on the treatment of simple endometrial hyperplasia, the only difference being that Letrozole presents fewer side effects than Megestrol acetate in patients with this condition.

Funding

Abnormal Uterine Bleeding Research Center of Semnan University of Medical Sciences, Semnan, Iran.

Trial Registration: IRCT2015031011504N5

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Acknowledgements

This study was supported and funded by the Abnormal Uterine Bleeding Research Center of Semnan University of Medical Sciences as a thesis project for achieving specialty degree in the field of gynecology and obstetrics with registry clinical trials code IRCT2015031011504N5. No funding or sponsorship was received for article processing charges. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.

Disclosures

Sanam Moradan, Niaz Nikkhah and Majid Mirmohammadkhanai declare no conflicts of interest.

Compliance with Ethics Guidelines

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study.

Data Availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

Author information

Authors and Affiliations

  1. Gynecologist, Abnormal Uterine Bleeding Research Center, Semnan University of Medical Sciences, Semnan, Iran

    Sanam Moradan & Niaz Nikkhah

  2. Epidemiologist, Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran

    Majid Mirmohammadkhanai

Authors
  1. Sanam Moradan
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  2. Niaz Nikkhah
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  3. Majid Mirmohammadkhanai
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Corresponding author

Correspondence to Majid Mirmohammadkhanai.

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Moradan, S., Nikkhah, N. & Mirmohammadkhanai, M. Comparing the Administration of Letrozole and Megestrol Acetate in the Treatment of Women with Simple Endometrial Hyperplasia without Atypia: A Randomized Clinical Trial. Adv Ther 34, 1211–1220 (2017). https://doi.org/10.1007/s12325-017-0509-8

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