Clomiphene Citrate in Infertile PCOS Patients

NCT00501839 | Withdrawn Phase 4

• 1 other identifier: 05/2006a
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Clomiphene citrate (CC) represents the first therapeutic option for treating the anovulatory infertility in PCOS patients because it is characterized by low costs, limited dose-dependent side effects, and simplicity of administration and management due to no need for ongoing monitoring. Excellent results in terms of ovulations have been obtained using CC. However, only 50% of patients who ovulates under CC will conceive. The exact explanation for the discrepancy between the ovulation and pregnancy rates is unknown, but several hypotheses on the anti-estrogenic effects that CC exerts on the ovary and uterus have been suggested. To date, few data are available on the optimal schedule for CC administration, and it is unknown how long patients who ovulate under CC should continue treatment before switching to second-line ovulation induction therapy. The aim of the study was to define the clinical benefits of CC administration according to its duration of administration.

Conditions

Polycystic Ovary Syndrome; Infertility

Keywords

Anovulation; Clomiphene citrate; Infertility; PCOS; Treatment

Outcome Measures

Primary Outcomes (1)

• Cumulative pregnancy rate

  12 months

Secondary Outcomes (1)

• Ovulation rate Abortion rate Live-birth rate Adverse events Multiple pregnancy rate

  21 months

Study Arms (3)

Group A

ACTIVE COMPARATOR

Cyclic progestogens for nine months

Drug: clomiphene citrate

Group B

ACTIVE COMPARATOR

CC treatment for further three cycles at the same ovulating doses followed by six months of cyclic progestogens

Drug: clomiphene citrate

Group C

ACTIVE COMPARATOR

CC administration at the same ovulating doses for nine cycles

Drug: clomiphene citrate

Interventions

clomiphene citrate DRUG

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Polycystic ovary syndrome (using NIH criteria)
• Anovulatory infertility (using WHO criteria)
• Previous three CC-stimulated ovulatory cycles

You may not qualify if:

• Age \<18 or \>35 years
• Severe obesity (BMI \>35)
• Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
• Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
• Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs
• Intention to start a diet or a specific program of physical activity
• Organic pelvic diseases
• Previous pelvic surgery
• Suspected peritoneal factor infertility
• Tubal or male factor infertility or sub-fertility

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Pugliese Hospital

Catanzaro, Catanzaro, CZ, Italy, 88100, Italy

Location

Related Publications (2)

• Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Clomiphene citrate versus metformin as first-line approach for the treatment of anovulation in infertile patients with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Sep;92(9):3498-503. doi: 10.1210/jc.2007-1009. Epub 2007 Jun 26.

  PMID: 17595241 BACKGROUND

• Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.

  PMID: 15840746 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility; Anovulation

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Stefano Palomba, MD

  Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro

  PRINCIPAL INVESTIGATOR

• Francesco Orio, MD

  Department of Endocrinology, University "Federico II" of Naples

  PRINCIPAL INVESTIGATOR

• Achille Tolino, MD

  Department of Obstetrics & Gynecology, University "Federico II" of Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: August 1, 2008
• Primary Completion: September 1, 2010
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

IT (1)