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

NCT03566225 | Completed Early Phase 1 FDA Drug

• 1 other identifier: AinShamaU
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Pioglitazone

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Pregnancy rate diagnosed by U/S at five weeks after missed menses

  3 months

Study Arms (2)

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

Pioglitazone DRUG

Insulin sensitizing agents

Also known as: Glustazon

Group A

Metformin DRUG

Insulin sensitizing agent

Also known as: Cidophage

Group B

Clomiphene Citrate DRUG

Induction drug

Also known as: Clomid

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Univerisity

Cairo, Egypt

Location

MeSH Terms

Interventions

Pioglitazone; Metformin; Clomiphene

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Asmaa Salih, Resident

  AinShams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cairo

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 25, 2018
• Study Start: January 30, 2018
• Primary Completion: February 28, 2021
• Study Completion: March 30, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

EG (1)