Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin | RxWiki

Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin

Overview[ - collapse ][ - ]

Purpose	The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.
Condition	Polycystic Ovary Syndrome Insulin Resistance
Intervention	Drug: Metformin Drug: Clomiphene citrate
Phase	Phase 3
Sponsor	OVO R & D
Responsible Party	OVO R & D
ClinicalTrials.gov Identifier	NCT01638988
First Received	July 9, 2012
Last Updated	March 12, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	July 9, 2012
Last Updated Date	March 12, 2014
Start Date	September 2013
Estimated Primary Completion Date	December 2015
Current Primary Outcome Measures	Biochemical pregnancy [Time Frame: 1 month] [Designated as safety issue: No]Rate of biochemical pregnancy
Current Secondary Outcome Measures	Ovulation rate [Time Frame: 1 month] [Designated as safety issue: No]Ovulation rate Live birth rate [Time Frame: 6 months] [Designated as safety issue: Yes] Spontaneous abortion rate [Time Frame: 6 months] [Designated as safety issue: No] BMI and waist size changing [Time Frame: 6 months] [Designated as safety issue: No] Insulin resistance changing [Time Frame: 6 months] [Designated as safety issue: No] AMH correlation/variation in function of Metformin [Time Frame: 6 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin
Official Title	Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome (PCOS) and a Resistance to Insulin. Randomised Controlled Study
Brief Summary	The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Polycystic Ovary Syndrome Insulin Resistance
Intervention	Drug: Metformin cycle 2000 mg of Metformin : Day 1 to day 30; beginning with 1/2 tablet by day with an increasing until 4 pills by day to 6 cycle 2000 mg of Metformin : Day 1 ot day 30; 4 pills of Metformin by day Positive pregnancy test : 4 pills of Metformin by day until 12 weeks of pregnancy Other Names: MetforminDrug: Clomiphene citrate Cycle 1: Day 3 to day 7; 50 mg; 1 tablet of Clomiphene Citrate by day Cycle 2: Day 3 to day 7; 100 mg; 1 tablet of Clomiphene Citrate two times a day Cycle 3 to 6 : Day 3 to day 7; 150 mg; 1 tablet of Clomiphene Citrate 3 times a day Other Names: Clomiphene citrate
Study Arm (s)	Experimental: Metformin Active Comparator: Clomiphene Citrate

Recruitment Information[ + expand ][ + ]

Recruitment Status	Suspended
Estimated Enrollment	401
Estimated Completion Date	December 2015
Estimated Primary Completion Date	May 2015
Eligibility Criteria	Inclusion Criteria: - Women aged from 18 to 35 - Infertility for a period of a year or more or 6 month of irregular menstrual cycle - PCOS under the Rotterdam criteria - Insulin resistance HOMA-IR > 2.5 - Normal semen analysis values - Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH, Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase, SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total cholesterol, Triglycerides, oral glucose tolerance test Exclusion Criteria: - Tubular factor - Normal ovarian reserve - Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen, weight-loss agent or oral contraceptives in the past 6 months - Neoplasia - BMI > 35 - Renal, hepatic or cardiac failure - Lactic, acidosis antecedent
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT01638988
Other Study ID Numbers	OVO-12-17
Has Data Monitoring Committee	No
Information Provided By	OVO R & D
Study Sponsor	OVO R & D
Collaborators	Not Provided
Investigators	Principal Investigator: Jacques Kadoch, Dr clinique ovo
Verification Date	March 2014

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