Effect of NMN (Nicotinamide Mononucleotide) on Polycystic... | NCT05305677

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

NCT05305677

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Nov 25, 2025Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

Polycystic Ovary Syndrome

Interventions

NMN intervention
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Mar 14, 2022

First Submission Date that Met QC Criteria

Mar 22, 2022

First Posted Date

Mar 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2025

Last Update Posted Date

Nov 25, 2025Actual

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NMN intervention	Experimental	8 weeks of NMN	Dietary Supplement: NMN intervention
Placebo	Placebo Comparator	8 weeks of NMN-free placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NMN intervention	Dietary Supplement	NMN capsules (total of 600mg/day) for 8 weeks	NMN intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Testosterone level	Changes of testosterone level in serum after intervention.	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.	From enrollment to the end of treatment at 8 weeks
Menstrual cycle	The changes of menstrual cycle frequency after intervention.	before and after 8 weeks of intervention

Secondary Outcomes

Measure	Description	Time Frame
Luteinizing hormone (LH) level	Changes of LH level in serum after intervention.	From enrollment to the end of treatment at 8 weeks
Follicle-stimulating hormone (FSH) level	Changes of FSH level in serum after intervention.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291