Semaglutide and Polycystic Ovarian Syndrome: an Emerging... | NCT06222437

Studies
Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

NCT06222437

Sponsor

Methodist Health System

Status

Withdrawn

Last Update Posted

Mar 23, 2026Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Polycystic Ovary Syndrome

Interventions

Semaglutide

Countries

Not provided

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IRB did not approve

Expanded Access Info

Start Date

Feb 2026Estimated

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Jan 16, 2024

First Submission Date that Met QC Criteria

Jan 16, 2024

First Posted Date

Jan 24, 2024Actual

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

Mar 19, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.

Detailed Description

The study mainly focused for the following objectives:

To determine the effect of semaglutide on ovulation and menstrual regularity. To determine the effect of semaglutide on androgen levels, namely testosterone, sex hormone binding globulin, and changes in hirsutism.

To determine changes in weight, body mass index (BMI), and Glycated Hemoglobin( HbA1c) with semaglutide therapy.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Protocol group	Experimental	PCOS women in the age 18 to 45 years	Drug: Semaglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	effectiveness of semaglutide in PCOS	Protocol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of appropriate weekly dose	To access the compliances of the therapy	4 weeks
Number of days on therapy	To access the persistence on Semaglutide	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
measure the Weight in kilograms	To access the weight changes during therapy	4 weeks
Numbers of days with exercise changes	To access the ability to do exercise during the therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-45
Body mass index(BMI) > 30
Diagnosis of PCOS
Normal thyroid stimulating hormone, prolactin, follicle-stimulating hormone (FSH), estradiol, and normal progesterone

Exclusion Criteria:

Medications excluded: any hormone-containing contraceptive - oral contraceptive pills, Progesterone-only pill, depo-provera, oral provera, progesterone-containing intrauterine contraceptive device
Letrozole, clomiphene citrate, FSH therapy
Androgen receptor blockers
5α reductase inhibitors
Insulin
Hysterectomy
Endometrial ablation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with PCOS

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000591245	semaglutide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided