NCT06199544

Brief Summary

Currently available medications for PCOS are symptom(s) oriented but have limitations because of its complex pathophysiology. The most preferred drug against PCOS is metformin which act as an insulin sensitizer to improve insulin-glucose metabolism and anovulatory cycles in PCOS. However, its use is associated with various side effects such as bloating, diarrhea and nausea. Thus, it is imperative to explore various other alternatives to combat this gynecological problem.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

January 29, 2023

Last Update Submit

December 29, 2023

Conditions

Comparative Study

Outcome Measures

Primary Outcomes (1)

  • Improvement in the menstrual regularity of the patient

    The lengths and duration of menstrual cycle of patients will be measured

    1 year

Study Arms (3)

Control group

EXPERIMENTAL

metformin 500 mg twice a day

Drug: Metformin

Picolin group

EXPERIMENTAL

Picolin 500mg thrice a day

Drug: Metformin

Rasoline

EXPERIMENTAL

Rasoline 500mg thrice a day

Drug: Metformin

Interventions

MetforminDRUG

Comparing the effect of drugs on symptoms of PCOS

Also known as: Picolin, Rasoline
Control groupPicolin groupRasoline

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • \) Patients with severe adverse drug reactions, 2) Record of cardiovascular, diabetes, hepatic and neoplastic disorders or other concurrent medical illnesses, 3) Hormonal contraceptive used within 6 months, or anti-obesity drugs within 3 months of the study, 4) Irregular menstrual bleeding other than PCOS and 5) Positive pregnancy test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa ul mulk memorial hospital

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Leena Hameed, M.Phil.

CONTACT

00923333037145Leena.hameed@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 29, 2023

First Posted

January 10, 2024

Study Start

October 1, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)