---
title: Does adding tibolone to a hormone treatment help severe PMS? | Niyora
description: Adding tibolone to leuprolide acetate (a GnRH agonist) did not reduce the hormone's benefits and may reduce hot flushes. The hormone treatment significantly i
url: https://niyora.com/research/papers/use-of-leuprolide-acetate-plus-tibolone-in-the-treatment-of-severe-premenstrual-2001/
---

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- Does adding tibolone to a hormone treatment help severe PMS?

Randomised trial, 2001

# Does adding tibolone to a hormone treatment help severe PMS?

Adding tibolone to leuprolide acetate (a GnRH agonist) did not reduce the hormone's benefits and may reduce hot flushes. The hormone treatment significantly improved psychological and physical PMS symptoms.

 Moderate study design

30 women aged 23 to 29 with severe PMS

## What they did

Double-blind, placebo-controlled trial in 30 women aged 23 to 29 with severe PMS. Women received leuprolide acetate 3.75 mg by injection plus either tibolone 2.5 mg daily or placebo daily for 2 cycles. Symptoms were measured using a visual analog scale during the last 7 days of each cycle.

## What they found

Mean scores for psychological and physical PMS symptoms improved significantly during treatment. No significant difference was found between women treated with tibolone and those given placebo. Women who received tibolone experienced significantly fewer hot flushes per day compared to the placebo group.

## What it means for you

This hormone and drug combination may offer long-term treatment for severe PMS. However, tibolone provides little additional benefit beyond the hormone treatment alone, except for reducing hot flushes. The study is small and from one hospital in Italy.

30

women studied

2

treatment cycles

2.5 mg

daily tibolone dose

## About the study

Original title Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome Authors Di Carlo C, Palomba S, Tommaselli GA et al. Journal Fertility and sterility Year 2001 Study design Randomised trial What was tested Leuprolide acetate 3.75 mg injection plus tibolone 2.5 mg daily or placebo for 2 cycles Open access Yes Read the paper [doi.org/10.1016/s0015-0282(00)01707-6](https://doi.org/10.1016/s0015-0282(00)01707-6)

## Topics

[Premenstrual syndrome (PMS)](https://niyora.com/research/topics/condition-pms/)[GnRH agonists and ovarian suppression](https://niyora.com/research/topics/treatment-gnrh/)[Estradiol, progesterone and hormone therapy](https://niyora.com/research/topics/treatment-hormone-therapy/)

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