Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome (NMN)

November 20, 2025 updated by: Peking University Third Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Individuals who are 20 to 40 years old;
  2. BMI < 25 kg/m2;
  3. 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).
  4. Individuals who can insist on continuous monitoring in the outpatient clinic.
  5. Individuals who are not participating in other research projects currently or 3 months before the intervention.

Exclusion Criteria:

  1. Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
  2. Individuals who are during pregnant, lactation or menopause.
  3. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
  4. Individuals who take niacin, nicotinamide, or other vitamin B-related supplementation currently or within the past 2 months.
  5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
  6. Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
  7. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
  8. A medical history of severe cardiovascular and cerebrovascular diseases.
  9. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
  10. Individuals who drink more than 15g of alcohol per day or have a smoking habit.
  11. Individuals who need drug treatment for any mental illness such as epilepsy and depression.
  12. Cancer patients.
  13. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NMN intervention
8 weeks of NMN
Dietary supplement: NMN intervention
NMN capsules (total of 600mg/day) for 8 weeks
Placebo Comparator: Placebo
8 weeks of NMN-free placebo
Other: Placebo
NMN-free placebo capsules for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Testosterone level
Time Frame: From enrollment to the end of treatment at 8 weeks
Changes of testosterone level in serum after intervention.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
Menstrual cycle
Time Frame: before and after 8 weeks of intervention
The changes of menstrual cycle frequency after intervention.
before and after 8 weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Luteinizing hormone (LH) level
Time Frame: From enrollment to the end of treatment at 8 weeks
Changes of LH level in serum after intervention.
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
Changes of FSH level in serum after intervention.
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 HOMA-IR index (fasting insulin * fasting glucose/22.5) after intervention.
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
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
From enrollment to the end of treatment at 8 weeks
Multi-omics
Time Frame: From enrollment to the end of treatment at 8 weeks
Collect samples before and after 2, 4, 8 weeks of intervention
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2021577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patients' information is requested to be confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings