Polycystic Ovary SyndromeNMNNCT05305677
Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome
A study testing NMN intervention in people with Polycystic Ovary Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of the study is to understand the effect of Nicotinamide mononucleotide (NMN) on patients with polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- NMN intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who are 20 to 40 years old;
- BMI < 25 kg/m2;
- Individuals with PCOS should meet all the Rotterdam diagnostic criteria: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
- Individuals who can insist on continuous monitoring in the outpatient clinic.
- Individuals who are not participating in other research projects currently or 3 months before the intervention.
Who cannot join
- Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
- Individuals who are during pregnant, lactation or menopause.
- Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
- Individuals who take niacin, nicotinamide, or other vitamin B-related supplementation currently or within the past 2 months.
- Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
- Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
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- Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
- A medical history of severe cardiovascular and cerebrovascular diseases.
- Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
- Individuals who drink more than 15g of alcohol per day or have a smoking habit.
- Individuals who need drug treatment for any mental illness such as epilepsy and depression.
- Cancer patients.
- Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Polycystic Ovary Syndrome
The purpose of the study is to understand the effect of Nicotinamide mononucleotide (NMN) on patients with polycystic ovary syndrome.
Read the detailed description
This study aims to evaluate the effects of NMN on reproductive endocrine and metabolism, chronic inflammation, and reproductive outcomes in women with polycystic ovary syndrome (PCOS), and to explore its underlying mechanisms to provide the intervention strategies for PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- NMN intervention, Placebo
- Keywords
- polycystic ovary syndrome, reproductive endocrine, metabolism, gut microbiota, NMN
- 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.
NMN interventionDietary supplement
NMN capsules (total of 600mg/day) for 8 weeks
PlaceboOther
NMN-free placebo capsules for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| NMN intervention | Experimental | 8 weeks of NMN Receives: Dietary Supplement: NMN intervention |
| Placebo | Placebo comparator | 8 weeks of NMN-free placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone level
Changes of testosterone level in serum after intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Antral follicle counts
The number of antral follicle counts in each ovary will be determined using transvaginal ultrasonography for each participant.
Measured: From enrollment to the end of treatment at 8 weeks
Menstrual cycle
The changes of menstrual cycle frequency after intervention.
Measured: before and after 8 weeks of intervention
Secondary outcomes (6)
Luteinizing hormone (LH) level
Changes of LH level in serum after intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Follicle-stimulating hormone (FSH) level
Changes of FSH level in serum after intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
Changes in HOMA-IR index (fasting insulin * fasting glucose/22.5) after intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Changes in other endocrine hormones
Measured: From enrollment to the end of treatment at 8 weeks
Changes in blood NAD+ level and related metabolites
Measured: From enrollment to the end of treatment at 8 weeks
Multi-omics
Collect samples before and after 2, 4, 8 weeks of intervention
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305677
- Sponsor's protocol ID
- M2021577
- Acronym
- NMN
- Status last verified
- Dec 2024
- First submitted
- 14 Mar 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients' information is requested to be confidential.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05305677
- Acronym / sponsor ID
- NMN / M2021577
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, reproductive endocrine, metabolism, gut microbiota, NMN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 Mar 2022 (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 purpose of the study is to understand the effect of Nicotinamide mononucleotide (NMN) on patients with polycystic ovary syndrome.
Detailed description
This study aims to evaluate the effects of NMN on reproductive endocrine and metabolism, chronic inflammation, and reproductive outcomes in women with polycystic ovary syndrome (PCOS), and to explore its underlying mechanisms to provide the intervention strategies for PCOS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMN intervention | Experimental | Dietary Supplement: NMN intervention8 weeks of NMN |
| Placebo | Placebo comparator | Other: Placebo8 weeks of NMN-free placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals who are 20 to 40 years old;
- BMI < 25 kg/m2;
- Individuals with PCOS should meet all the Rotterdam diagnostic criteria: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
- Individuals who can insist on continuous monitoring in the outpatient clinic.
- Individuals who are not participating in other research projects currently or 3 months before the intervention.
Key exclusion criteria (13 listed)
- Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
- Individuals who are during pregnant, lactation or menopause.
- Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
- Individuals who take niacin, nicotinamide, or other vitamin B-related supplementation currently or within the past 2 months.
- Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
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 |
|---|---|---|
| NMN interventionNMN capsules (total of 600mg/day) for 8 weeks | Dietary supplement | NMN intervention |
| PlaceboNMN-free placebo capsules for 8 weeks | Other | Placebo |
Primary outcome
Testosterone level
Time frame: From enrollment to the end of treatment at 8 weeks
Changes of testosterone level in serum after intervention.
Antral follicle counts
Time frame: From enrollment to the end of treatment at 8 weeks
The number of antral follicle counts in each ovary will be determined using transvaginal ultrasonography for each participant.
Menstrual cycle
Time frame: before and after 8 weeks of intervention
The changes of menstrual cycle frequency after intervention.
6 secondary outcomes
Luteinizing hormone (LH) level
Time frame: From enrollment to the end of treatment at 8 weeks
Follicle-stimulating hormone (FSH) level
Time frame: From enrollment to the end of treatment at 8 weeks
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in other endocrine hormones
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in blood NAD+ level and related metabolites
Time frame: From enrollment to the end of treatment at 8 weeks
Multi-omics
Time frame: From enrollment to the end of treatment at 8 weeks
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 25 Nov 2025.
- Individual participant dataSharing planned: No. Patients' information is requested to be confidential.
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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 NMN intervention in people with Polycystic Ovary Syndrome, run by Peking University Third Hospital at 1 site in China.
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 5 inclusion and 13 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 25 Nov 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 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. 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.
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?
Testosterone level (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 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 25 Nov 2025.