PCOSEarly Phase 1PCONCT04204044
Comparison of Myoinositol and Metformin in PCO
A Early Phase 1 study testing Metformin Hydrochloride and Myo-inositol in people with PCOS, run by Rashid Latif Medical College at 1 site in Pakistan.
Trial summary
Aim of the study is to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Metformin Hydrochloride and Myo-inositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2020to 25 Jul 2021
- Phase
- Early Phase 1
- 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 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- It will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group.
Who cannot join
- Hyperprolactinemia
- Cushing's disease
- Hypothyroidism/ Hyperthyroidism
- Pregnancy and nursing
- Established type 1 or type 2 diabetes mellitus
- Any history of drug intake e.g. anti-diabetic or estrogen and progesterone
Show all 10Show fewer
- History of treatment for the same complaint taken in the last 3 months
- Unable to come for regular follow-ups
- Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology
- Known allergic to these drugs
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rashid Latif Medical College
Lahore, Punjab Province, 54200
Musarrat ul.Hasnain, FCPS,MHPE, 00923006509943, shahbal@gmail.com
LAMIA YUSUF, FCPS,MHPE, 00923214549179, doclamia@hotmail.com
About this study
Official title: A Comparative Study of Myo Inositol and Metformin in Improving Biochemical and Clinical Profile of Patients With Polycystic Ovarian Syndrome; a Randomized Clinical Trial
Aim of the study is to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome.
The secondary outcome measured will be the rate of pregnancy, miscarriage and term pregnancy among these patients inducted in the study.
It will be a Three-arm prospective double-blind study. this clinical trial will be registered in Public registry. this RCT will be based on CONSORT statement. The patient coming to Gynecology OPD will be randomized into 3 groups GROUP A ( metformin 500 mg TDS), GROUP B( myoinositol 2mg x BD ), GROUP C.(both metformin,\& myoinositol).each group will take folic acid and will be asked for lifestyle modifications.
Read the detailed description
PCOS is a common endocrine disorder in women of reproductive age associated with insulin resistance. Metformin and Myo-inositol being insulin sensitizers improve biochemical parameters. it is aimed to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome.
Inclusion criteria: will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group.
Patients with history of Hyperprolactinemia, Cushing's disease, Hypothyroidism/ Hyperthyroidism, Pregnancy and nursing, Established type 1 or type 2 diabetes mellitus, Any history of drug intake e.g. anti-diabetic or estrogen and progesterone, History of treatment for the same complaint taken in the last 3 months, Unable to come for regular follow-ups, Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology and known allergic to these drugs would be excluded.
- Conditions
- PCOS
- Being tested
- Metformin Hydrochloride, Myo-inositol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
Also called Folic acid
Metformin Hydrochloride is used in PCO
Myo-inositolDrug
Also called Folic Acid
Myo inositol used in PCO
| Study group | Role | What they receive |
|---|---|---|
| GROUP A ( metformin 500 mg TDS) | Experimental | Life style modifications, Weight reduction and folic acid will be prescribed with metformin 500 mg three times a day Receives: Drug: Metformin Hydrochloride |
| GROUP B( myoinositol 2000mg x BD ) | Experimental | Life style modifications, Weight reduction and folic acid will be prescribed with myoinositol 2000 mg two times a day Receives: Drug: Myo-inositol |
| GROUP C.(both metformin,& myoinositol) | Experimental | Life style modifications, Weight reduction and folic acid will be prescribed with both metformin,\& myoinositol three and two times a day respectively Receives: Drug: Metformin Hydrochloride; Drug: Myo-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual cycle regulation
In the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea.Improvement in the biochemical and clinical profile of patients with the polycystic syndrome
Measured: Follow up at 3rd and 6th months
change in weight
change in weight and BMI. Weight in Kg(s) and height will be measured in meter(s). BMI will be calculated by dividing weight in Kg with height in meter square
Measured: Follow up at 3rd and 6th months
Secondary outcomes (1)
Pregnancy / Miscarriage
The secondary outcome measured will be the rate of conception/pregnancy, miscarriage and term pregnancy among these patients inducted in the study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Nov 2020 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion25 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- GROUP A ( Metformin 500 mg TDS), GROUP B( Myoinositol 2000 mg x BD ), GROUP C.(both metformin,\& myoinositol)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rashid Latif Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia yusuf, Rashid Latif Medical College
- Investigators
- LAMIA YUSUF, FCPS,MHPE, Principal investigator, rlmc lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204044
- Sponsor's protocol ID
- IRB/2019/027
- Acronym
- PCO
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Myo Inositol and Metformin in Improving Biochemical and Clinical Profile of Patients With Polycystic Ovarian Syndrome; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04204044
- Acronym / sponsor ID
- PCO / IRB/2019/027
- Conditions
- PCOS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Rashid Latif Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 25 Jul 2021 (estimated)
- First posted
- 18 Dec 2019 (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.
Aim of the study is to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome.
The secondary outcome measured will be the rate of pregnancy, miscarriage and term pregnancy among these patients inducted in the study.
It will be a Three-arm prospective double-blind study. this clinical trial will be registered in Public registry. this RCT will be based on CONSORT statement. The patient coming to Gynecology OPD will be randomized into 3 groups GROUP A ( metformin 500 mg TDS), GROUP B( myoinositol 2mg x BD ), GROUP C.(both metformin,\& myoinositol).each group will take folic acid and will be asked for lifestyle modifications.
Detailed description
PCOS is a common endocrine disorder in women of reproductive age associated with insulin resistance. Metformin and Myo-inositol being insulin sensitizers improve biochemical parameters. it is aimed to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome.
Inclusion criteria: will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group.
Patients with history of Hyperprolactinemia, Cushing's disease, Hypothyroidism/ Hyperthyroidism, Pregnancy and nursing, Established type 1 or type 2 diabetes mellitus, Any history of drug intake e.g. anti-diabetic or estrogen and progesterone, History of treatment for the same complaint taken in the last 3 months, Unable to come for regular follow-ups, Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology and known allergic to these drugs would be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- GROUP A ( Metformin 500 mg TDS), GROUP B( Myoinositol 2000 mg x BD ), GROUP C.(both metformin,\& myoinositol)
| Arm | Type | Receives |
|---|---|---|
| GROUP A ( metformin 500 mg TDS) | Experimental | Drug: Metformin HydrochlorideLife style modifications, Weight reduction and folic acid will be prescribed with metformin 500 mg three times a day |
| GROUP B( myoinositol 2000mg x BD ) | Experimental | Drug: Myo-inositolLife style modifications, Weight reduction and folic acid will be prescribed with myoinositol 2000 mg two times a day |
| GROUP C.(both metformin,& myoinositol) | Experimental | Drug: Metformin Hydrochloride, Drug: Myo-inositolLife style modifications, Weight reduction and folic acid will be prescribed with both metformin,\& myoinositol three and two times a day respectively |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- It will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group.
Key exclusion criteria (10 listed)
- Hyperprolactinemia
- Cushing's disease
- Hypothyroidism/ Hyperthyroidism
- Pregnancy and nursing
- Established type 1 or type 2 diabetes mellitus
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 |
|---|---|---|
| Metformin HydrochlorideAlso: Folic acidMetformin Hydrochloride is used in PCO | Drug | GROUP A ( metformin 500 mg TDS), GROUP C.(both metformin,& myoinositol) |
| Myo-inositolAlso: Folic AcidMyo inositol used in PCO | Drug | GROUP B( myoinositol 2000mg x BD ), GROUP C.(both metformin,& myoinositol) |
Primary outcome
Menstrual cycle regulation
Time frame: Follow up at 3rd and 6th months
In the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea.Improvement in the biochemical and clinical profile of patients with the polycystic syndrome
change in weight
Time frame: Follow up at 3rd and 6th months
change in weight and BMI. Weight in Kg(s) and height will be measured in meter(s). BMI will be calculated by dividing weight in Kg with height in meter square
1 secondary outcome
Pregnancy / Miscarriage
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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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.
LAMIA YUSUF, FCPS,MHPE principal investigator
rlmc lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin Hydrochloride and Myo-inositol in people with PCOS, run by Rashid Latif Medical College 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 1 inclusion and 10 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 27 Oct 2020. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 LAMIA YUSUF, FCPS,MHPE (00923214549179, doclamia@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual cycle regulation (time frame: Follow up at 3rd and 6th months). The study lists 2 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 27 Oct 2020.