PCOS (Polycystic Ovary Syndrome)NCT07168837
Letrozole and Cabergoline Versus Letrozole Alone in Ovulation Induction
A study testing Letrozole tablets in people with PCOS (Polycystic Ovary Syndrome), run by Al-Azhar University at 1 site in Egypt.
Trial summary
Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorders in women of reproductive age. According to the World Health Organization (WHO) estimation revealed over 116 million women (3.4%) are affected by PCOS worldwide. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Letrozole tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 10 May 2024
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with PCOS according to Rotterdam criteria (Rotterdam, 2004) as:
- Menstrual anomalies like amenorrhea (no cycles in the past 6 months), oligomenorrhoea (cycles lasting longer than 35 days), or long cycles.
- Clinical and/or biochemical hyperandrogenism.
- Ultrasound (USG) appearance of polycystic ovaries (multiple cysts >12 in number of 2-9 mm size).
Who cannot join
- Patient with liver and kidney disease.
- Congenital adrenal hyperplasia.
- Hypothalamic or pituitary cause of amenorrhea.
- Primary hyperprolactinemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Letrozole and Cabergoline Versus Letrozole Alone in Ovulation Induction Among PCOS Patients in Assiut Governorate
Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorders in women of reproductive age. According to the World Health Organization (WHO) estimation revealed over 116 million women (3.4%) are affected by PCOS worldwide.
Owing to the intricacy of this condition, various sets of diagnostic criteria have been initiated for the confirmation of PCOS which are: National Institute of Health, Rotterdam's Criteria, Androgen Excess and PCOS society. The prevalence of PCOS is estimated at about 4 to 21 % when it is diagnosed according to the Rotterdam criteria accounting for 75% of cases with anovulatory infertility.
Read the detailed description
In women with PCOS, the serum FSH levels are slightly lower during the follicular phase, therefore aromatization of excessive androgens is insufficient, and the follicles will not undergo the final FSH-dependent maturation in a dominant follicle. Furthermore, the serum level of anti-Mullerian hormone (AMH) is elevated. AMH counteracts the FSH-driven aromatase complex activity, so high AMH levels will inhibit granulosa cell conversion of androgens to estrogens and have a detrimental effect on final follicular maturation.
Previous studies showed that 30% of patients with PCOS show a modest rise in prolactin level. Increasing serum prolactin in these patients could be detected in both follicular and luteal phase of the normal and stimulated cycles. Dopamine release from the hypothalamus inhibits prolactin secretion, and it also affects the secretion of gonadotropins. When this inhibitory effect of dopamine is reduced, prolactin secretion will increase in addition to abnormalities in gonadotropins including luteinizing hormones.
Cabergoline which is a dopamine receptor agonist, with higher affinity to dopamine D2 receptors had improved uterine perfusion and achieved a better ovulatory response in PCOS patients, due to its ability to inhibit the vascular endothelial growth factor (VEGF) secretion in luteinized granulosa cells. Other studies concluded that Cabergoline use could normalize androgen level and therefore improve the menstrual irregularity in women with PCOS.
Letrozole is a third-generation aromatase inhibitor. It blocks the conversion of C-19 androgens to C-18 estrogens by competitively inhibiting the enzyme, aromatase (cytochrome P-450), which is an essential step in estrogen biosynthesis in the ovary and other tissues.The subsequent feedback to the hypothalamus containing reduced estrogen levels, triggers a compensatory increase in hypothalamic gonadotropin-releasing hormone (GnRH) secretion, and thus an increased release of pituitary gonadotropins FSH \& LH. These gonadotropins subsequently promote growth of the follicles and stimulate ovulation. Letrozole has 99.9% bioavailability after oral administration. It has a single dose terminal half-life of 42 hours.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Letrozole tablets
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole tabletsDrug
Also called Cabergoline
to compare between Letrozole withncabergoline and letrozole alone in ovulation induction among PCOS female patients.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Letrozole with cabergoline) | Active comparator | About 50 of infertile female with PCOs whom received Letrozole, 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles in addition to cabergoline, 0.5 mg weekly for 12 weeks. Receives: Drug: Letrozole tablets |
| Group B (Letrozole only) | Active comparator | About 50 of infertile female with PCOs whom received Letrozole only, 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles. Receives: Drug: Letrozole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Ovulation
Detection of Ovulation among the women whom participated and took the drugs of the study by making Serial ultrasound monitoring started from day 10 of menstrual cycle.
Measured: One week from drug taking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start10 Jan 2023
- Primary completion1 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Hamouda Mohammed Ramadan, Al-Azhar University
- Investigators
- El-Kotb Hasan El-Kotb El-Saeidy, Professor, Study chair, Obstetrics and Gynecology Department, Faculty of medicine,Al-Azhar University, Assiut.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168837
- Sponsor's protocol ID
- Letrozole and Cabergoline
- Status last verified
- Jan 2023
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole and Cabergoline Versus Letrozole Alone in Ovulation Induction Among PCOS Patients in Assiut Governorate
- ClinicalTrials.gov ID
- NCT07168837
- Acronym / sponsor ID
- Letrozole and Cabergoline
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 11 Sep 2025 (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.
Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorders in women of reproductive age. According to the World Health Organization (WHO) estimation revealed over 116 million women (3.4%) are affected by PCOS worldwide.
Owing to the intricacy of this condition, various sets of diagnostic criteria have been initiated for the confirmation of PCOS which are: National Institute of Health, Rotterdam's Criteria, Androgen Excess and PCOS society. The prevalence of PCOS is estimated at about 4 to 21 % when it is diagnosed according to the Rotterdam criteria accounting for 75% of cases with anovulatory infertility.
Detailed description
In women with PCOS, the serum FSH levels are slightly lower during the follicular phase, therefore aromatization of excessive androgens is insufficient, and the follicles will not undergo the final FSH-dependent maturation in a dominant follicle. Furthermore, the serum level of anti-Mullerian hormone (AMH) is elevated. AMH counteracts the FSH-driven aromatase complex activity, so high AMH levels will inhibit granulosa cell conversion of androgens to estrogens and have a detrimental effect on final follicular maturation.
Previous studies showed that 30% of patients with PCOS show a modest rise in prolactin level. Increasing serum prolactin in these patients could be detected in both follicular and luteal phase of the normal and stimulated cycles. Dopamine release from the hypothalamus inhibits prolactin secretion, and it also affects the secretion of gonadotropins. When this inhibitory effect of dopamine is reduced, prolactin secretion will increase in addition to abnormalities in gonadotropins including luteinizing hormones.
Cabergoline which is a dopamine receptor agonist, with higher affinity to dopamine D2 receptors had improved uterine perfusion and achieved a better ovulatory response in PCOS patients, due to its ability to inhibit the vascular endothelial growth factor (VEGF) secretion in luteinized granulosa cells. Other studies concluded that Cabergoline use could normalize androgen level and therefore improve the menstrual irregularity in women with PCOS.
Letrozole is a third-generation aromatase inhibitor. It blocks the conversion of C-19 androgens to C-18 estrogens by competitively inhibiting the enzyme, aromatase (cytochrome P-450), which is an essential step in estrogen biosynthesis in the ovary and other tissues.The subsequent feedback to the hypothalamus containing reduced estrogen levels, triggers a compensatory increase in hypothalamic gonadotropin-releasing hormone (GnRH) secretion, and thus an increased release of pituitary gonadotropins FSH \& LH. These gonadotropins subsequently promote growth of the follicles and stimulate ovulation. Letrozole has 99.9% bioavailability after oral administration. It has a single dose terminal half-life of 42 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Letrozole with cabergoline) | Active comparator | Drug: Letrozole tabletsAbout 50 of infertile female with PCOs whom received Letrozole, 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles in addition to cabergoline, 0.5 mg weekly for 12 weeks. |
| Group B (Letrozole only) | Active comparator | Drug: Letrozole tabletsAbout 50 of infertile female with PCOs whom received Letrozole only, 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women diagnosed with PCOS according to Rotterdam criteria (Rotterdam, 2004) as:
Key exclusion criteria (4 listed)
- Patient with liver and kidney disease.
- Congenital adrenal hyperplasia.
- Hypothalamic or pituitary cause of amenorrhea.
- Primary hyperprolactinemia.
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 |
|---|---|---|
| Letrozole tabletsAlso: Cabergolineto compare between Letrozole withncabergoline and letrozole alone in ovulation induction among PCOS female patients. | Drug | Group A (Letrozole with cabergoline), Group B (Letrozole only) |
Primary outcome
Identification of Ovulation
Time frame: One week from drug taking
Detection of Ovulation among the women whom participated and took the drugs of the study by making Serial ultrasound monitoring started from day 10 of menstrual cycle.
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 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
El-Kotb Hasan El-Kotb El-Saeidy, Professor study chair
Obstetrics and Gynecology Department, Faculty of medicine,Al-Azhar University, Assiut.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole tablets in people with PCOS (Polycystic Ovary Syndrome), run by Al-Azhar University at 1 site in Egypt.
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 4 inclusion and 4 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 11 Sep 2025. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Identification of Ovulation (time frame: One week from drug taking). 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 11 Sep 2025.