Polycystic Ovarian Syndrome (PCOS)Phase 4NCT07769476
Comparison of Clomiphene Alone Versus Clomiphene Plus Sildenafil for Ovulation in Women With Polycystic Ovary Syndrome
A Phase 4 study testing Clomiphene Citrate 100 mg and Sildenafil Citrate 25Mg Tab in people with Polycystic Ovarian Syndrome (PCOS) and Polyendocrine Metabolic Ovarian Syndrome (PMOS), run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS), Polyendocrine Metabolic Ovarian Syndrome (PMOS)
- What is being tested?
- Clomiphene Citrate 100 mg and Sildenafil Citrate 25Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 30 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with PCOS,
- Sub-fertility attributed to PCOS, > 2 years
Who cannot join
- Comorbidities; diabetes, hypertension
- Chronic medical illness (liver, heart, kidney disease)
- Undergone ovarian drilling
- Recent administration of hormonal therapy
- Abnormal prolactin levels (>500 mIU/L), or thyroid function tests (TSH >5.2 mIU/L, T3 <70 ng/dl and T4 <5.2 μg/dl)
- Obstructed fallopian tubes documented on hysterosalpingography and
- Abnormal semen analysis of their partners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clomiphene Citrate Alone Versus Clomiphene Citrate Plus Sildenafil Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
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:
Read more
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.
- Participants in Group A will receive clomiphene citrate 100 mg once daily from days 3-7 of the menstrual cycle, plus sildenafil citrate 25 mg twice daily from days 8-12.
- Participants in Group B will receive clomiphene citrate 100 mg once daily from days 3-7, plus a placebo twice daily from days 8-12.
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.
- Being tested
- Clomiphene Citrate 100 mg, Sildenafil Citrate 25Mg Tab, Placebo
- Keywords
- Clomiphene Citrate, Sildenafil Citrate, Ovulation Induction, Pregnancy, Polycystic Ovarian Syndrome, Endometrial Thickness, Subfertility
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene Citrate 100 mgDrug
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 25Mg TabDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene Citrate + Sildenafil Citrate | Experimental | Oral Clomiphene Citrate and Sildenafil Citrate will be given to participants in this Arm Receives: Drug: Clomiphene Citrate 100 mg; Drug: Sildenafil Citrate 25Mg Tab |
| Clomiphene Citrate + Placebo | Placebo comparator | Participants in this arm will be given clomiphene citrate and placebo Receives: Drug: Clomiphene Citrate 100 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initiation of treatment (1st cycle) through completion of third treatment cycle, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Jul 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Ramzan, Nishtar Medical University
- Investigators
- Hajira M Associate Professor, FCPS, Study chair, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769476
- Sponsor's protocol ID
- U1111-1345-1484
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clomiphene Citrate Alone Versus Clomiphene Citrate Plus Sildenafil Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT07769476
- Acronym / sponsor ID
- U1111-1345-1484
- Keywords
- Clomiphene Citrate, Sildenafil Citrate, Ovulation Induction, Pregnancy, Polycystic Ovarian Syndrome, Endometrial Thickness, Subfertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Participants in Group A will receive clomiphene citrate 100 mg once daily from days 3-7 of the menstrual cycle, plus sildenafil citrate 25 mg twice daily from days 8-12.
- Participants in Group B will receive clomiphene citrate 100 mg once daily from days 3-7, plus a placebo twice daily from days 8-12.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene Citrate + Sildenafil Citrate | Experimental | Drug: Clomiphene Citrate 100 mg, Drug: Sildenafil Citrate 25Mg TabOral Clomiphene Citrate and Sildenafil Citrate will be given to participants in this Arm |
| Clomiphene Citrate + Placebo | Placebo comparator | Drug: Clomiphene Citrate 100 mg, Drug: PlaceboParticipants in this arm will be given clomiphene citrate and placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with PCOS,
- Sub-fertility attributed to PCOS, > 2 years
Key exclusion criteria (7 listed)
- Comorbidities; diabetes, hypertension
- Chronic medical illness (liver, heart, kidney disease)
- Undergone ovarian drilling
- Recent administration of hormonal therapy
- Abnormal prolactin levels (>500 mIU/L), or thyroid function tests (TSH >5.2 mIU/L, T3 <70 ng/dl and T4 <5.2 μg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clomiphene Citrate 100 mgClomiphene citrate 100 mg administered orally once daily from menstrual cycle days 3-7 for ovulation induction. Treatment will be repeated for 12 weeks. | Drug | Clomiphene Citrate + Placebo, Clomiphene Citrate + Sildenafil Citrate |
| Sildenafil Citrate 25Mg TabSildenafil 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. | Drug | Clomiphene Citrate + Sildenafil Citrate |
| PlaceboMatching 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. | Drug | Clomiphene Citrate + Placebo |
Primary outcome
Pregnancy
Time frame: From initiation of treatment (1st cycle) through completion of third treatment cycle, up to 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hajira M Associate Professor, FCPS study chair
Nishtar Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clomiphene Citrate 100 mg and Sildenafil Citrate 25Mg Tab in people with Polycystic Ovarian Syndrome (PCOS) and Polyendocrine Metabolic Ovarian Syndrome (PMOS), run by Nishtar Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy (time frame: From initiation of treatment (1st cycle) through completion of third treatment cycle, up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.