Menstrual IrregularitiesPhase 1/2mprmihNCT03757923
Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
A Phase 1/2 study testing TAB METFORMIN and TAB PIOGLITAZONE in people with Menstrual Irregularities and Hyperandrogenism, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Menstrual Irregularities, Hyperandrogenism
- What is being tested?
- TAB METFORMIN and TAB PIOGLITAZONE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jun 2018to Jan 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women of age 18-40 with primary or secondary infertility.
- Polycystic ovarian syndrome daignosed using rotterdam criteria.
- Not taken any medication before for PCOS.
Who cannot join
- Women having type 1 or type 2 diabetes mellitus.
- Abnormal kidney or liver function.
- Hypertension or heart disease.
- Gonadotrophin induction or ovarian drilling before will not be included in this study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dow University Hospital OJHA
Karachi, Sindh, 75270
About this study
To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients.
Read the detailed description
This study will be a prospective, randomized, open label, multicentre study. It will be carried out in outpatients department of Obstetrics and gynecology, at the Dow university of Hospital and mamji hospital Karachi.
The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or hyperprolactinemia.
Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute to greater concentration of free androgens in blood, cut off of insulin level for insulin resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing agents has been recently proposed as a useful treatment option in women with pcos, which by reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.
- Conditions
- Menstrual Irregularities, Hyperandrogenism
- Being tested
- TAB METFORMIN, TAB PIOGLITAZONE
- Keywords
- PCO, Metformin
- Medical subject headings
- Menstruation Disturbances, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAB METFORMINDrug
INSULIN SENSITIZING AGENTS
TAB PIOGLITAZONEDrug
INSULIN SENSITIZING AGENT
| Study group | Role | What they receive |
|---|---|---|
| metformin | Experimental | TAB METFORMIN 500mg TDS Receives: Drug: TAB METFORMIN |
| pioglitazone | Experimental | TAB PIOGLITAZONE 30 mg OD Receives: Drug: TAB PIOGLITAZONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIRSUTISM
Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
Measured: 3 months
POLYCYSTIC OVARIES
assessment on ultrasound (qualitative-present/not present)
Measured: 3 months
MENSTRUAL IRREGULARITIES
assessment on history(qualitative-present/not present)
Measured: 3 months
BMI
weight and height will be combined to report BMI in kg/m2
Measured: 3 months
Secondary outcomes (4)
SERUM FASTING INSULIN
unit of measure: uIU/ml
Measured: 3 months
FASTING BLOOD SUGAR
unit of measure:mg/dl
Measured: 3 months
FREE TESTOSTERONE
unit of measure :nmol/l
Measured: 3 months
FREE ANDROGEN INDEX
numerical
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start18 Jun 2018
- Primary completion17 Dec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual IrregularitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trail
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jahan Ara Ainuddin, Dow University of Health Sciences
- Investigators
- Bader F Zuberi, FCPS, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757923
- Sponsor's protocol ID
- DowUHS3
- Acronym
- mprmih
- Status last verified
- Nov 2018
- First submitted
- 30 Jul 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
- ClinicalTrials.gov ID
- NCT03757923
- Acronym / sponsor ID
- mprmih / DowUHS3
- Conditions
- Menstrual Irregularities, Hyperandrogenism
- Keywords
- PCO, Metformin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 17 Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients.
Detailed description
This study will be a prospective, randomized, open label, multicentre study. It will be carried out in outpatients department of Obstetrics and gynecology, at the Dow university of Hospital and mamji hospital Karachi.
The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or hyperprolactinemia.
Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute to greater concentration of free androgens in blood, cut off of insulin level for insulin resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing agents has been recently proposed as a useful treatment option in women with pcos, which by reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trail
| Arm | Type | Receives |
|---|---|---|
| metformin | Experimental | Drug: TAB METFORMINTAB METFORMIN 500mg TDS |
| pioglitazone | Experimental | Drug: TAB PIOGLITAZONETAB PIOGLITAZONE 30 mg OD |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women of age 18-40 with primary or secondary infertility.
- Polycystic ovarian syndrome daignosed using rotterdam criteria.
- Not taken any medication before for PCOS.
Key exclusion criteria (4 listed)
- Women having type 1 or type 2 diabetes mellitus.
- Abnormal kidney or liver function.
- Hypertension or heart disease.
- Gonadotrophin induction or ovarian drilling before will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAB METFORMININSULIN SENSITIZING AGENTS | Drug | metformin |
| TAB PIOGLITAZONEINSULIN SENSITIZING AGENT | Drug | pioglitazone |
Primary outcome
HIRSUTISM
Time frame: 3 months
Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
POLYCYSTIC OVARIES
Time frame: 3 months
assessment on ultrasound (qualitative-present/not present)
MENSTRUAL IRREGULARITIES
Time frame: 3 months
assessment on history(qualitative-present/not present)
BMI
Time frame: 3 months
weight and height will be combined to report BMI in kg/m2
4 secondary outcomes
SERUM FASTING INSULIN
Time frame: 3 months
FASTING BLOOD SUGAR
Time frame: 3 months
FREE TESTOSTERONE
Time frame: 3 months
FREE ANDROGEN INDEX
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bader F Zuberi, FCPS study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAB METFORMIN and TAB PIOGLITAZONE in people with Menstrual Irregularities and Hyperandrogenism, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jahan A Ainuddin (03012530961, jahanaraainuddin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIRSUTISM (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.