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The effect of clomiphen citrate with flutamid in PCOS patients

The effect of Flutamid on induction of ovulation in polycystic ovary syndrome patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201105081141N10
Enrollment
96
Registered
2011-10-16
Start date
2005-04-03
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS patients with clomid failure. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention 1: 100 mg clomiphen citrate on days 3 to 7 of cycle and flutamid 250 mg per day from day 3 to the end of the menstrual cycle in the first cycle. Intervention 2: Interventi
Treatment - Drugs
Intervention 1: 100 mg clomiphen citrate on days 3 to 7 of cycle and flutamid 250 mg per day from day 3 to the end of the menstrual cycle in the first cycle
Intervention 2: 100 mg clomiphen citrate on days 3 to 7 of cycle and placebo from day 3 to the end of the menstrual cycle in the first cycle.
Intervention 3: 150 mg clomiphen citrate on days 3 to 7 of cycle and flutamid 250 mg per day from day 3 to the end of the menstrual cycle in the second cycle
Intervention 4: 150 mg clomiphen citrate on days 3 to 7 of cycle and placebo from day 3 to the end of the menstrual cycle in the second cycle.

Sponsors

Reproductive medicine research center, Royan Institute, ACECR
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 37 Years

Inclusion criteria

Inclusion criteria: Inclusion: Age under 37 years; PCOS diagnosed by the Rotterdam and legro and lanham criteria, by two of the following three features : 1) oligo or an ovulation, 2) clinical and or biochemical signs of hyper androgenism, or 3) polycystic ovaries; previously documented dominant follicle or follicles (R12mm mean diameter) on trans vaginal ultrasound follicular monitoring; normal uterine cavity and patent tubes by either hyserosalpin go gram or laparoscopy and hysteroscopy; normal fasting glucose; normal serum prolactione and thyroid stimulating hormone, estradiol, LH, testestron, normal semen analysis by world health organization criteria. Exclusion: Discontent of athending the study and being allergic to the intended drugs (Flutamid or clomiphene citrate); hyper prolactinemia; thyroid dysfunction; age over 37; and BMI >30.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Improving ovulation, number of dominant follicles. Timepoint: number of dimnant follicles>18 mm in the mid cycle. Method of measurement: sonography.

Secondary

MeasureTime frame
Regulating of cycles, during of stimulation. Timepoint: observation of follicles by sonography. Method of measurement: sonography and measurement of progestron in 19 th and 21 th cycle.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shohreh Irani

Royan institute

sh-irani@royaninstitute.org+98 21 2356 2000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026