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 journalArticle

40 Citations (Scopus)

Abstract

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
Volume75
Issue number2
DOIs
Publication statusPublished - 2001

Fingerprint

tibolone
Leuprolide
Premenstrual Syndrome
Gonadotropin-Releasing Hormone
Placebos
Therapeutics
Psychology
Hospital Obstetrics and Gynecology Department
Controlled Clinical Trials
Therapeutic Uses
Gynecology
Visual Analog Scale
Italy
Tablets
Signs and Symptoms

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Di Carlo, C., Palomba, S., Tommaselli, G. A., Guida, M., Di Spiezio Sardo, A., & Nappi, C. (2001). Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome. Fertility and Sterility, 75(2), 380-384. https://doi.org/10.1016/S0015-0282(00)01707-6

Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome. / Di Carlo, Costantino; Palomba, Stefano; Tommaselli, Giovanni A.; Guida, Maurizio; Di Spiezio Sardo, Attilio; Nappi, Carmine.

In: Fertility and Sterility, Vol. 75, No. 2, 2001, p. 380-384.

Research output: Contribution to journalArticle

Di Carlo, C, Palomba, S, Tommaselli, GA, Guida, M, Di Spiezio Sardo, A & Nappi, C 2001, 'Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome', Fertility and Sterility, vol. 75, no. 2, pp. 380-384. https://doi.org/10.1016/S0015-0282(00)01707-6
Di Carlo, Costantino ; Palomba, Stefano ; Tommaselli, Giovanni A. ; Guida, Maurizio ; Di Spiezio Sardo, Attilio ; Nappi, Carmine. / Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome. In: Fertility and Sterility. 2001 ; Vol. 75, No. 2. pp. 380-384.
@article{d55bc9c33e7a4a01a1d45e43a66030ca,
title = "Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome",
abstract = "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.",
keywords = "Add-back therapy, GnRH-a, Leuprolide acetate, Premenstrual syndrome, Tibolone",
author = "{Di Carlo}, Costantino and Stefano Palomba and Tommaselli, {Giovanni A.} and Maurizio Guida and {Di Spiezio Sardo}, Attilio and Carmine Nappi",
year = "2001",
doi = "10.1016/S0015-0282(00)01707-6",
language = "English",
volume = "75",
pages = "380--384",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier Inc.",
number = "2",

}

TY - JOUR

T1 - Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome

AU - Di Carlo, Costantino

AU - Palomba, Stefano

AU - Tommaselli, Giovanni A.

AU - Guida, Maurizio

AU - Di Spiezio Sardo, Attilio

AU - Nappi, Carmine

PY - 2001

Y1 - 2001

N2 - 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.

AB - 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.

KW - Add-back therapy

KW - GnRH-a

KW - Leuprolide acetate

KW - Premenstrual syndrome

KW - Tibolone

UR - http://www.scopus.com/inward/record.url?scp=0035145477&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035145477&partnerID=8YFLogxK

U2 - 10.1016/S0015-0282(00)01707-6

DO - 10.1016/S0015-0282(00)01707-6

M3 - Article

C2 - 11172843

AN - SCOPUS:0035145477

VL - 75

SP - 380

EP - 384

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

IS - 2

ER -