Polyendocrine Metabolic Ovarian Syndrome (PMOS)NCT07379502
Endometrial Response in Polyendocrine Metabolic Ovarian Syndrome (PMOS) Treated With Letrozole Alone or With Added Estradiol Valerate
A study testing Letrozole (Aromatase Inhibitors) and Letrozole (Aromatase Inhibitors) + Estradiol valerate in people with Polyendocrine Metabolic Ovarian Syndrome (PMOS), run by CMH Kharian Medical College at 1 site in Pakistan.
Trial summary
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polyendocrine Metabolic Ovarian Syndrome (PMOS)
- What is being tested?
- Letrozole (Aromatase Inhibitors) and Letrozole (Aromatase Inhibitors) + Estradiol valerate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Mar 2026to 31 Aug 2026
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 20-35 years
- Clinical diagnosis of PMOS (Rotterdam criteria)
Who cannot join
- Endocrine disorders other than PMOS
- Endometrial pathology or uterine malformations
- Allergy to letrozole or estradiol
- Hormonal therapy within last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endometrial Response in Women With Poorly Primed Endometrial Lining in Diagnosed Polyendocrine Metabolic Ovarian Syndrome (PMOS) Treated With Letrozole Alone or With Added Estradiol Valerate
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.
Read the detailed description
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. However, one of the drawbacks of aromatase inhibitors is suboptimal endometrial development, which may adversely affect implantation and pregnancy outcomes.
Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. Limited data exist on whether adding estradiol to letrozole truly improves the endometrial response and clinical pregnancy rates in women with PCOS. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.
- Being tested
- Letrozole (Aromatase Inhibitors), Letrozole (Aromatase Inhibitors) + Estradiol valerate
- Keywords
- Letrozole, Estradiol Valerate, Endometrial response, Endometrial thickness, Polyendocrine Metabolic Ovarian Syndrome (PMOS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole (Aromatase Inhibitors)Drug
30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days
Letrozole (Aromatase Inhibitors) + Estradiol valerateDrug
30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days
| Study group | Role | What they receive |
|---|---|---|
| letrozole | Active comparator | 30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days Receives: Drug: Letrozole (Aromatase Inhibitors) |
| letrozole plus estradiol valerate | Experimental | 30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days Receives: Drug: Letrozole (Aromatase Inhibitors) + Estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness (mm) on day of ovulation trigger
Endometrial thickness will be measured on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle.
Measured: 12th day of cycle 1 (Each cycle is 28 days)
Pattern of endometrium (Trilaminar or Non-trilaminar) on the day of ovulation trigger
Endometrial pattern will be seen on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle
Measured: 12th day of cycle 1 (Each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Mar 2026
- Primary completion30 Jun 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyendocrine Metabolic Ovarian Syndrome (PMOS)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Kharian Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maryum Noor Malik, CMH Kharian Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379502
- Sponsor's protocol ID
- CKMC/IERB/AC-00256
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Response in Women With Poorly Primed Endometrial Lining in Diagnosed Polyendocrine Metabolic Ovarian Syndrome (PMOS) Treated With Letrozole Alone or With Added Estradiol Valerate
- ClinicalTrials.gov ID
- NCT07379502
- Acronym / sponsor ID
- CKMC/IERB/AC-00256
- Keywords
- Letrozole, Estradiol Valerate, Endometrial response, Endometrial thickness, Polyendocrine Metabolic Ovarian Syndrome (PMOS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CMH Kharian Medical CollegeOther government
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 30 Jan 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.
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.
Detailed description
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. However, one of the drawbacks of aromatase inhibitors is suboptimal endometrial development, which may adversely affect implantation and pregnancy outcomes.
Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. Limited data exist on whether adding estradiol to letrozole truly improves the endometrial response and clinical pregnancy rates in women with PCOS. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| letrozole | Active comparator | Drug: Letrozole (Aromatase Inhibitors)30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days |
| letrozole plus estradiol valerate | Experimental | Drug: Letrozole (Aromatase Inhibitors) + Estradiol valerate30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 20-35 years
- Clinical diagnosis of PMOS (Rotterdam criteria)
Key exclusion criteria (4 listed)
- Endocrine disorders other than PMOS
- Endometrial pathology or uterine malformations
- Allergy to letrozole or estradiol
- Hormonal therapy within last 3 months
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 (Aromatase Inhibitors)30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days | Drug | letrozole |
| Letrozole (Aromatase Inhibitors) + Estradiol valerate30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days | Drug | letrozole plus estradiol valerate |
Primary outcome
Endometrial thickness (mm) on day of ovulation trigger
Time frame: 12th day of cycle 1 (Each cycle is 28 days)
Endometrial thickness will be measured on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle.
Pattern of endometrium (Trilaminar or Non-trilaminar) on the day of ovulation trigger
Time frame: 12th day of cycle 1 (Each cycle is 28 days)
Endometrial pattern will be seen on Transvaginal ultrasound on 12th day in a 28 day 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 10 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (Aromatase Inhibitors) and Letrozole (Aromatase Inhibitors) + Estradiol valerate in people with Polyendocrine Metabolic Ovarian Syndrome (PMOS), run by CMH Kharian Medical College 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 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 10 Sep 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. 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?
Endometrial thickness (mm) on day of ovulation trigger (time frame: 12th day of cycle 1 (Each cycle is 28 days)). The study lists 2 primary outcomes in all. 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 10 Sep 2026.