A Phase 4 interventional study of Clomiphene Citrate 100 mg and Sildenafil Citrate 25Mg Tab in Polycystic Ovarian Syndrome (PCOS) and Polyendocrine Metabolic Ovarian Syndrome (PMOS), sponsored by Nishtar Medical University. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Nishtar Medical University · Phase 4, Interventional, and Treatment
The goal of this randomized clinical trial is to compare the effectiveness of clomiphene citrate alone with clomiphene citrate combined with sildenafil citrate for inducing ovulation and achieving pregnancy in women with polycystic ovary syndrome (PCOS) who have difficulty becoming pregnant.
The main question the study aims to answer is:
Does adding sildenafil citrate to clomiphene citrate increase the chance of ovulation and pregnancy compared with clomiphene citrate alone in women with PCOS?
The study will include 98 women aged 18-45 years with PCOS and a history of difficulty achieving pregnancy for more than 2 years. Participants will be randomly assigned to one of two groups.
Treatment will be given for 12 weeks. Participants will be assessed for ovulation, pregnancy, and endometrial thickness. Ovulation will be assessed using transvaginal ultrasound and/or a blood progesterone test. Pregnancy will be assessed using a urine pregnancy test and/or ultrasound.
The primary hypothesis is that women receiving clomiphene citrate plus sildenafil citrate will have a higher rate of pregnancy than women receiving clomiphene citrate alone. The study will also determine whether adding sildenafil improves ovulation and endometrial thickness.
Exclusion Criteria:
Oral Clomiphene Citrate and Sildenafil Citrate will be given to participants in this Arm
Drug: Clomiphene Citrate 100 mg · Drug: Sildenafil Citrate 25Mg Tab
Participants in this arm will be given clomiphene citrate and placebo
Drug: Clomiphene Citrate 100 mg · Drug: Placebo
Clomiphene citrate 100 mg administered orally once daily from menstrual cycle days 3-7 for ovulation induction. Treatment will be repeated for 12 weeks.
Sildenafil citrate 25 mg administered orally twice daily from menstrual cycle days 8-12, in addition to clomiphene citrate, for ovulation induction. Treatment will be repeated for 12 weeks.
Matching placebo containing starch administered orally twice daily from menstrual cycle days 8-12, in addition to clomiphene citrate. Treatment will be repeated for 12 weeks.
Pregnancy
Pregnancy will be considered achieved when a urine human chorionic gonadotropin (hCG) test is positive after 7 days of a missed menstrual period and/or a gestational sac is detected by ultrasound.
Time frame: From initiation of treatment (1st cycle) through completion of third treatment cycle, up to 12 weeks
Ovulation
Ovulation will be considered present when a collapsed follicle and free fluid in the pouch of Douglas are observed on transvaginal ultrasound and/or serum progesterone is ≥3 ng/mL. Transvaginal ultrasound will be start around cycle day 10-12, then repeat every 1-2 days until evidence of ovulation. Serum progesterone will be measured approximately 7 days after the expected ovulation (often around cycle day 21 in a 28-day cycle).
Time frame: From initiation of treatment (first cycle) through completion of the third cycle, up to 12 weeks
Endometrial Thickness
Endometrial thickness will be measured by transvaginal ultrasonography once during each treatment cycle, at the peri-ovulatory assessment when the dominant follicle reaches approximately 18-22 mm in diameter, before evidence of follicular rupture. Measurements will therefore be obtained during each of the three treatment cycles.
Time frame: From initiation of treatment (first cycle) through completion of the third cycle, up to 12 weeks
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Nishtar Medical University