Pioglitazone Versus Metformin as First Treatment in Infer... | NCT03566225

Studies
Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome

NCT03566225

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jun 2, 2021Actual

Enrollment

400Actual

Phase

Early Phase 1

Conditions

Pioglitazone

Interventions

Pioglitazone
Metformin
Clomiphene Citrate

Countries

Egypt

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

May 2021

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

Jan 30, 2018Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Mar 30, 2021Actual

First Submitted Date

May 26, 2018

First Submission Date that Met QC Criteria

Jun 20, 2018

First Posted Date

Jun 25, 2018Actual

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

May 30, 2021

Last Update Posted Date

Jun 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment

metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
Induction of ovulation by clomiphene citate 50 mg tablets to all participants

Detailed Description

Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment

metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
Induction of ovulation by clomiphene citate 50 mg tablets once or twice dialy 12hours apart starting from the 3rd day of menstrual cycle and continue for five days during treatment with insulin sensitizing agents to group A and B.

Participants with oligomenorrhea will recieve two tablets of noreththisterone 5 mg tab every 12 hours for 5 days to allow for withdrawal bleeding before start ovulation induction

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction	Drug: Pioglitazone Drug: Clomiphene Citrate
Group B	Placebo Comparator	Metformin in adose 1500 mg dialy will be administered + clomiphene citrate	Drug: Metformin Drug: Clomiphene Citrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pioglitazone	Drug	Insulin sensitizing agents	Group A	Glustazon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate	Pregnancy rate diagnosed by U/S at five weeks after missed menses	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women age 20_35
BMI 18_29.9
Women with PCOS(diagnosed by using Rotterdam criteria
Infertility is cause for seeking tfeatment

Exclusion Criteria:

Causes of infertility other than PCOS.
patient refusal.
Contraindication of any of the drugs used in the study
Cause of oligo/anovulation other than PCOS
Current or previous (within the last six month) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetics, antiobesity drugs or other hormonal drugs.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asmaa Salih, Resident	AinShams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams Univerisity		Cairo			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D000077205	Pioglitazone
D008687	Metformin
D002996	Clomiphene

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided