Polycystic Ovary Syndrome (PCOS)Phase 4NCT03151005

The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

A Phase 4 study testing Metformin-GLP-1 Receptor Agonist and Metformin-Oral Contraceptive(OC) in people with Polycystic Ovary Syndrome (PCOS) and Overweight, run by Xinqiao Hospital of Chongqing at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Polycystic Ovary Syndrome (PCOS), Overweight, Obesity
What is being tested?: Metformin-GLP-1 Receptor Agonist and Metformin-Oral Contraceptive(OC)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChina
Study dates: 1 Jul 2017to 23 Apr 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism.
Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks.
Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese [body mass index (BMI) >=24 kg/m2 or waistline>=85cm ].
All subjects had normal thyroid-stimulating hormone and prolactin levels.

Who cannot join

smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions.
age below 18 yr or over 50 yr.
postmenopausal.
uncontrolled hypertension (blood pressure >=160/100 mm Hg).
preexisting OPs or GLP-1 agonists supplementation
alcohol intake greater than 20 g/d, or pregnancy.

Show all 9Show fewer

signs of liver or renal failure or active liver disease (ALT > 2.5× the upper limit of normal values).
PLT<60*10^9/L,Hb<100g/L, smoking, alcohol use.
The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400037

Other trials in China

About this study

Official title: Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

Read the detailed description

Groups:

Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

Time Point:

Initial treatment;

Post-treatment (4w);

Post-treatment (8w);

Post-treatment (12w);

Assess reproductive functions and cardiovascular risk factors.

Conditions: Polycystic Ovary Syndrome (PCOS), Overweight, Obesity
Being tested: Metformin-GLP-1 Receptor Agonist, Metformin-Oral Contraceptive(OC)
Keywords: Polycystic Ovary Syndrome (PCOS), Overweight, Obesity, GLP-1 Agonist, Oral contraceptives (OCs), Metformin, Reproductive Disorders, Cardiovascular risk factor, Lipid Metabolism
Medical subject headings: Polycystic Ovary Syndrome, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Metformin-GLP-1 Receptor AgonistDrug
Also called Metformin-exenatide/liraglutide Therapy
metformin oral with exenatide/liraglutide subcutaneous injection.
Metformin-Oral Contraceptive(OC)Drug
Also called Metformin, Diane 35
metformin with Diane 35 oral intake.

Study groups in NCT03151005
Study group	Role	What they receive
Metformin-GLP-1 Receptor Agonist	Experimental	Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Receives: Drug: Metformin-GLP-1 Receptor Agonist
Metformin-Oral Contraceptive(OC)	Active comparator	Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Receives: Drug: Metformin-Oral Contraceptive(OC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of Reproductive Functions
Concentration of LH was measured in mIU/ml.
Measured: 12 weeks

Secondary outcomes (4)

Basic Vital Signs
Weight and height will be combined to report BMI in kg/m^2.
Measured: 12 weeks
Assessment of Liver Function
Alanine transaminase was measured in IU/L.
Measured: 12 weeks
Assessment of Blood Pressure
Systolic blood pressure was measured in mmHg.
Measured: 12 weeks
Assessment of Reproductive Function
Changes in testosterone levels were measured
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201723 Apr 2021

First posted12 May 2017
Study start1 Jul 2017
Primary completion1 Apr 2021
Study completion23 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Polycystic Ovary 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03151005
Sponsor's protocol ID: Xinqiao Endocrinology
Status last verified: Nov 2023
First submitted: 28 Apr 2017
Last updated: 4 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

Macut D, Bjekic-Macut J, Rahelic D, Doknic M. Insulin and the polycystic ovary syndrome. Diabetes Res Clin Pract. 2017 Aug;130:163-170. doi: 10.1016/j.diabres.2017.06.011. Epub 2017 Jun 12.
PubMed 28646699
Zhou BF; Cooperative Meta-Analysis Group of the Working Group on Obesity in China. Predictive values of body mass index and waist circumference for risk factors of certain related diseases in Chinese adults--study on optimal cut-off points of body mass index and waist circumference in Chinese adults. Biomed Environ Sci. 2002 Mar;15(1):83-96.
PubMed 12046553
Barthelmess EK, Naz RK. Polycystic ovary syndrome: current status and future perspective. Front Biosci (Elite Ed). 2014 Jan 1;6(1):104-19. doi: 10.2741/e695.
PubMed 24389146
Dumesic DA, Oberfield SE, Stener-Victorin E, Marshall JC, Laven JS, Legro RS. Scientific Statement on the Diagnostic Criteria, Epidemiology, Pathophysiology, and Molecular Genetics of Polycystic Ovary Syndrome. Endocr Rev. 2015 Oct;36(5):487-525. doi: 10.1210/er.2015-1018.
PubMed 26426951
Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.
PubMed 14688154
Yildiz BO, Bozdag G, Yapici Z, Esinler I, Yarali H. Prevalence, phenotype and cardiometabolic risk of polycystic ovary syndrome under different diagnostic criteria. Hum Reprod. 2012 Oct;27(10):3067-73. doi: 10.1093/humrep/des232. Epub 2012 Jul 9.
PubMed 22777527
Farrell K, Antoni MH. Insulin resistance, obesity, inflammation, and depression in polycystic ovary syndrome: biobehavioral mechanisms and interventions. Fertil Steril. 2010 Oct;94(5):1565-74. doi: 10.1016/j.fertnstert.2010.03.081. Epub 2010 May 14.
PubMed 20471009
Escobar-Morreale HF. Polycystic ovary syndrome: definition, aetiology, diagnosis and treatment. Nat Rev Endocrinol. 2018 May;14(5):270-284. doi: 10.1038/nrendo.2018.24. Epub 2018 Mar 23.
PubMed 29569621
Ruan X, Kubba A, Aguilar A, Mueck AO. Use of cyproterone acetate/ethinylestradiol in polycystic ovary syndrome: rationale and practical aspects. Eur J Contracept Reprod Health Care. 2017 Jun;22(3):183-190. doi: 10.1080/13625187.2017.1317735. Epub 2017 May 2.
PubMed 28463030
Wang YW, He SJ, Feng X, Cheng J, Luo YT, Tian L, Huang Q. Metformin: a review of its potential indications. Drug Des Devel Ther. 2017 Aug 22;11:2421-2429. doi: 10.2147/DDDT.S141675. eCollection 2017.
PubMed 28860713
Jiang Y, Wang Z, Ma B, Fan L, Yi N, Lu B, Wang Q, Liu R. GLP-1 Improves Adipocyte Insulin Sensitivity Following Induction of Endoplasmic Reticulum Stress. Front Pharmacol. 2018 Oct 16;9:1168. doi: 10.3389/fphar.2018.01168. eCollection 2018.
PubMed 30459598
Liao M, Li X, Zhang H, Zhou L, Shi L, Li W, Shen R, Peng G, Zhao H, Shao J, Wang X, Sun Z, Zheng H, Long M. Effects and plasma proteomic analysis of GLP-1RA versus CPA/EE, in combination with metformin, on overweight PCOS women: a randomized controlled trial. Endocrine. 2024 Jan;83(1):227-241. doi: 10.1007/s12020-023-03487-4. Epub 2023 Aug 31.
PubMed 37653215

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Recruiting
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All Polycystic Ovary Syndrome (PCOS) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients
ClinicalTrials.gov ID: NCT03151005
Acronym / sponsor ID: Xinqiao Endocrinology
Conditions: Polycystic Ovary Syndrome (PCOS), Overweight, Obesity
Keywords: Polycystic Ovary Syndrome (PCOS), Overweight, Obesity, GLP-1 Agonist, Oral contraceptives (OCs), Metformin, Reproductive Disorders, Cardiovascular risk factor
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Xinqiao Hospital of ChongqingUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 1 Apr 2021 (actual)
Study completion: 23 Apr 2021 (actual)
First posted: 12 May 2017 (actual)
Results: Posted 4 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Groups:

Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

Time Point:

Initial treatment;

Post-treatment (4w);

Post-treatment (8w);

Post-treatment (12w);

Assess reproductive functions and cardiovascular risk factors.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Metformin-GLP-1 Receptor Agonist	Experimental	Drug: Metformin-GLP-1 Receptor AgonistMetformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.
Metformin-Oral Contraceptive(OC)	Active comparator	Drug: Metformin-Oral Contraceptive(OC)Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism.
Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks.
Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese [body mass index (BMI) >=24 kg/m2 or waistline>=85cm ].
All subjects had normal thyroid-stimulating hormone and prolactin levels.

Key exclusion criteria (9 listed)

smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions.
age below 18 yr or over 50 yr.
postmenopausal.
uncontrolled hypertension (blood pressure >=160/100 mm Hg).
preexisting OPs or GLP-1 agonists supplementation

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
Metformin-GLP-1 Receptor AgonistAlso: Metformin-exenatide/liraglutide Therapymetformin oral with exenatide/liraglutide subcutaneous injection.	Drug	Metformin-GLP-1 Receptor Agonist
Metformin-Oral Contraceptive(OC)Also: Metformin, Diane 35metformin with Diane 35 oral intake.	Drug	Metformin-Oral Contraceptive(OC)

Primary outcome

Assessment of Reproductive Functions
Time frame: 12 weeks
Concentration of LH was measured in mIU/ml.

4 secondary outcomes

Basic Vital Signs
Time frame: 12 weeks
Assessment of Liver Function
Time frame: 12 weeks
Assessment of Blood Pressure
Time frame: 12 weeks
Assessment of Reproductive Function
Time frame: 12 weeks

Results and safety

Results posted to the registry on 4 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metformin-GLP-1 Receptor Agonist	35	30
Metformin-Oral Contraceptive(OC)	35	30

Primary outcome: Assessment of Reproductive Functions

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mIU/ml

Measure	Metformin-GLP-1 Receptor Agonist n = 30	Metformin-Oral Contraceptive(OC) n = 30
Value	5.52 (3.37)	5.33 (2.52)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 3.33% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metformin-GLP-1 Receptor Agonist	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Metformin-Oral Contraceptive(OC)	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30

Limitations and caveats (from the sponsor): Limitations of this trial include a relatively small sample size and single-center design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28646699Macut D, Bjekic-Macut J, Rahelic D, Doknic M. Insulin and the polycystic ovary syndrome. Diabetes Res Clin Pract. 2017 Aug;130:163-170. doi: 10.1016/j.diabres.2017.06.011. Epub 2017 Jun 12.
Results publication: PubMed 12046553Zhou BF; Cooperative Meta-Analysis Group of the Working Group on Obesity in China. Predictive values of body mass index and waist circumference for risk factors of certain related diseases in Chinese adults--study on optimal cut-off points of body mass index and waist circumference in Chinese adults. Biomed Environ Sci. 2002 Mar;15(1):83-96.
Results publication: PubMed 24389146Barthelmess EK, Naz RK. Polycystic ovary syndrome: current status and future perspective. Front Biosci (Elite Ed). 2014 Jan 1;6(1):104-19. doi: 10.2741/e695.
Results publication: PubMed 26426951Dumesic DA, Oberfield SE, Stener-Victorin E, Marshall JC, Laven JS, Legro RS. Scientific Statement on the Diagnostic Criteria, Epidemiology, Pathophysiology, and Molecular Genetics of Polycystic Ovary Syndrome. Endocr Rev. 2015 Oct;36(5):487-525. doi: 10.1210/er.2015-1018.
Results publication: PubMed 14688154Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.
Results publication: PubMed 22777527Yildiz BO, Bozdag G, Yapici Z, Esinler I, Yarali H. Prevalence, phenotype and cardiometabolic risk of polycystic ovary syndrome under different diagnostic criteria. Hum Reprod. 2012 Oct;27(10):3067-73. doi: 10.1093/humrep/des232. Epub 2012 Jul 9.
Results publication: PubMed 20471009Farrell K, Antoni MH. Insulin resistance, obesity, inflammation, and depression in polycystic ovary syndrome: biobehavioral mechanisms and interventions. Fertil Steril. 2010 Oct;94(5):1565-74. doi: 10.1016/j.fertnstert.2010.03.081. Epub 2010 May 14.
Results publication: PubMed 29569621Escobar-Morreale HF. Polycystic ovary syndrome: definition, aetiology, diagnosis and treatment. Nat Rev Endocrinol. 2018 May;14(5):270-284. doi: 10.1038/nrendo.2018.24. Epub 2018 Mar 23.
Results publication: PubMed 28463030Ruan X, Kubba A, Aguilar A, Mueck AO. Use of cyproterone acetate/ethinylestradiol in polycystic ovary syndrome: rationale and practical aspects. Eur J Contracept Reprod Health Care. 2017 Jun;22(3):183-190. doi: 10.1080/13625187.2017.1317735. Epub 2017 May 2.
Results publication: PubMed 28860713Wang YW, He SJ, Feng X, Cheng J, Luo YT, Tian L, Huang Q. Metformin: a review of its potential indications. Drug Des Devel Ther. 2017 Aug 22;11:2421-2429. doi: 10.2147/DDDT.S141675. eCollection 2017.
Results publication: PubMed 30459598Jiang Y, Wang Z, Ma B, Fan L, Yi N, Lu B, Wang Q, Liu R. GLP-1 Improves Adipocyte Insulin Sensitivity Following Induction of Endoplasmic Reticulum Stress. Front Pharmacol. 2018 Oct 16;9:1168. doi: 10.3389/fphar.2018.01168. eCollection 2018.
Derived from this study: PubMed 37653215Liao M, Li X, Zhang H, Zhou L, Shi L, Li W, Shen R, Peng G, Zhao H, Shao J, Wang X, Sun Z, Zheng H, Long M. Effects and plasma proteomic analysis of GLP-1RA versus CPA/EE, in combination with metformin, on overweight PCOS women: a randomized controlled trial. Endocrine. 2024 Jan;83(1):227-241. doi: 10.1007/s12020-023-03487-4. Epub 2023 Aug 31.
Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.

Related trials for Polycystic Ovary Syndrome (PCOS)

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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
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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.

Min long, MD principal investigator

Department of Endocrinology, Xinqiao Hospital,Third Military Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 4 Dec 2023. 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 China. 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.

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?

Yes. Results are posted in the registry (first posted 4 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Assessment of Reproductive Functions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03151005, which also lists 12 linked publications.

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 4 Dec 2023.