Prospective parallel randomized double-blind double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first line treatment for ovulation induction in non-obese anovulatory women with polycystic ovary syndrome

Enrico Carmina, Annamaria Colao, Stefano Palomba, Teresa Cascella, Francesco Manguso, Francesco Orio Jr., Achille Tolino, Fulvio Zullo, Tiziana Russo, Angela Falbo, Tiziana Russo

Risultato della ricerca: Article

211 Citazioni (Scopus)

Abstract

Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome ( PCOS), clomiphene citrate ( CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University "Magna Graecia" of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC ( 150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A(n = 45) and B( n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P < 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women. Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.
Lingua originaleEnglish
pagine (da-a)4068-4074
Numero di pagine7
RivistaTHE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
Volume90
Stato di pubblicazionePublished - 2005

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Clomiphene
Ovulation Induction
Polycystic Ovary Syndrome
Metformin
Controlled Clinical Trials
Pregnancy Rate
Ovulation
Fertility
Placebos
Outcome Assessment (Health Care)
Anovulation
Therapeutics
Induced Abortion
Birth Rate
Live Birth
Italy
Progesterone
Hemorrhage
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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Prospective parallel randomized double-blind double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first line treatment for ovulation induction in non-obese anovulatory women with polycystic ovary syndrome. / Carmina, Enrico; Colao, Annamaria; Palomba, Stefano; Cascella, Teresa; Manguso, Francesco; Orio Jr., Francesco; Tolino, Achille; Zullo, Fulvio; Russo, Tiziana; Falbo, Angela; Russo, Tiziana.

In: THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM, Vol. 90, 2005, pag. 4068-4074.

Risultato della ricerca: Article

Carmina, Enrico ; Colao, Annamaria ; Palomba, Stefano ; Cascella, Teresa ; Manguso, Francesco ; Orio Jr., Francesco ; Tolino, Achille ; Zullo, Fulvio ; Russo, Tiziana ; Falbo, Angela ; Russo, Tiziana. / Prospective parallel randomized double-blind double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first line treatment for ovulation induction in non-obese anovulatory women with polycystic ovary syndrome. In: THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM. 2005 ; Vol. 90. pagg. 4068-4074.
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title = "Prospective parallel randomized double-blind double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first line treatment for ovulation induction in non-obese anovulatory women with polycystic ovary syndrome",
abstract = "Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome ( PCOS), clomiphene citrate ( CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University {"}Magna Graecia{"} of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC ( 150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A(n = 45) and B( n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0{\%}, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2{\%}, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5{\%}, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3{\%}, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0{\%}, P < 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women. Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.",
author = "Enrico Carmina and Annamaria Colao and Stefano Palomba and Teresa Cascella and Francesco Manguso and {Orio Jr.}, Francesco and Achille Tolino and Fulvio Zullo and Tiziana Russo and Angela Falbo and Tiziana Russo",
year = "2005",
language = "English",
volume = "90",
pages = "4068--4074",
journal = "Journal of Clinical Endocrinology and Metabolism",
issn = "0021-972X",
publisher = "Oxford University Press",

}

TY - JOUR

T1 - Prospective parallel randomized double-blind double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first line treatment for ovulation induction in non-obese anovulatory women with polycystic ovary syndrome

AU - Carmina, Enrico

AU - Colao, Annamaria

AU - Palomba, Stefano

AU - Cascella, Teresa

AU - Manguso, Francesco

AU - Orio Jr., Francesco

AU - Tolino, Achille

AU - Zullo, Fulvio

AU - Russo, Tiziana

AU - Falbo, Angela

AU - Russo, Tiziana

PY - 2005

Y1 - 2005

N2 - Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome ( PCOS), clomiphene citrate ( CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University "Magna Graecia" of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC ( 150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A(n = 45) and B( n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P < 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women. Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.

AB - Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome ( PCOS), clomiphene citrate ( CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University "Magna Graecia" of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC ( 150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A(n = 45) and B( n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P < 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women. Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.

UR - http://hdl.handle.net/10447/3605

M3 - Article

VL - 90

SP - 4068

EP - 4074

JO - Journal of Clinical Endocrinology and Metabolism

JF - Journal of Clinical Endocrinology and Metabolism

SN - 0021-972X

ER -