Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome

Costantino Di Carlo, Stefano Palomba, Giovanni A. Tommaselli, Maurizio Guida, Attilio Di Spiezio Sardo, Carmine Nappi

Research output: Contribution to journalArticlepeer-review


Objective: To evaluate the effectiveness of GnRH agonist (GnRH-a) plus tibolone in the treatment of severe premenstrual syndrome (PMS). Design: Prospective, double-blind, placebo-controlled clinical trial. Setting: Department of Obstetrics and Gynecology, University of Naples 'Federico II,' Naples, Italy. Patient(s): Thirty patients affected by severe PMS, aged 23-29 years (mean age ± SD, 25.3 ± 2.9 years).Intervention(s): Treatment for two cycles with leuprolide acetate depot (3.75 mg IM for 28 days) in association with tibolone (2.5 mg/d orally) or placebo (1 tablet per day orally). Main Outcome Measure(s): The mean severity of each symptom and sign of PMS was evaluated using a visual analog scale during the last 7 days of each treatment cycle in comparison with the last 7 days of the cycle before treatment. Result(s): Mean scores for each of the adverse psychological/physical and positive psychological symptoms were significantly improved during treatment. No statistically significant difference was detected between patients treated with tibolone and placebo. A significantly lower number of hot flushes per day was observed in groups treated with GnRH-a and tibolone in comparison with GnRH-a and placebo. Conclusion(s): Tibolone administered in association with GnRH-a does not reduce the therapeutic effect of GnRH-a in women affected by PMS. Tibolone used in association with GnRH-a may provide long-term medical treatment for women with PMS.

Original languageEnglish
Pages (from-to)380-384
Number of pages5
JournalFertility and Sterility
Issue number2
Publication statusPublished - 2001


  • Add-back therapy
  • GnRH-a
  • Leuprolide acetate
  • Premenstrual syndrome
  • Tibolone

ASJC Scopus subject areas

  • Obstetrics and Gynaecology


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