PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesPhase 1NCT06170463
Insulin Sensitizers Role in Control of PCOS Vicious Cycle.
A Phase 1 study testing Metformin Hydrochloride, MI/DCI combination in 40:1 ratio and Combination of Metformin hydrochloride and MI/DCI in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Zagazig University at 1 site in Egypt.
Trial summary
PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
- What is being tested?
- Metformin Hydrochloride, MI/DCI combination in 40:1 ratio and Combination of Metformin hydrochloride and MI/DCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 15 Apr 2023
- Phase
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age;
- Residence;
- level of education \& type of work;
- Marital and fertility statuses, and if infertility was the main complaint;
- Presence of risk factors as sedentary lifestyle;
- Emotional stress and family history of PCOS;
Show all 9Show fewer
- Obesity-related medical disorders especially DM or MAFLD;
- History of previous treatment for PCOS and its outcomes;
- Menstrual pattern such as infrequent menstrual periods.
Who cannot join
- Women had other manifestations of metabolic syndrome:
- Cardiac manifestations of PCOS;
- Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS;
- Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications;
- Had morbid obesity with body mass index (BMI) >35 kg/m2;
- Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Insulin Sensitizers as Double-Weapon to Detonate PCOS-induced Vicious Circle
PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.
- Being tested
- Metformin Hydrochloride, MI/DCI combination in 40:1 ratio, Combination of Metformin hydrochloride and MI/DCI
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
Met Group Received metformin hydrochloride 500 mg tab 3 times Daily
MI/DCI combination in 40:1 ratioDrug
MI-group received MI/DCI combination in 40:1 ratio twice daily
Combination of Metformin hydrochloride and MI/DCIDrug
MM Group Received both Met and MI Groups Treatment
| Study group | Role | What they receive |
|---|---|---|
| Met Group | Active comparator | Not described Receives: Drug: Metformin Hydrochloride |
| MI Group | Active comparator | Not described Receives: Drug: MI/DCI combination in 40:1 ratio |
| MM Group | Active comparator | Not described Receives: Drug: Combination of Metformin hydrochloride and MI/DCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of mensural pattern
The Evaluation of the success rate of the applied regimens to gain mensural regular pattern in PCOS Women
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Aug 2022
- Primary completion1 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Walid Mohamed Elnagar, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170463
- Sponsor's protocol ID
- ZU-IRB#11195-21/6-2023
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Insulin Sensitizers as Double-Weapon to Detonate PCOS-induced Vicious Circle
- ClinicalTrials.gov ID
- NCT06170463
- Acronym / sponsor ID
- ZU-IRB#11195-21/6-2023
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 14 Dec 2023 (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.
PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Met Group | Active comparator | Drug: Metformin Hydrochloride |
| MI Group | Active comparator | Drug: MI/DCI combination in 40:1 ratio |
| MM Group | Active comparator | Drug: Combination of Metformin hydrochloride and MI/DCI |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age;
- Residence;
- level of education \& type of work;
- Marital and fertility statuses, and if infertility was the main complaint;
- Presence of risk factors as sedentary lifestyle;
Key exclusion criteria (6 listed)
- Women had other manifestations of metabolic syndrome:
- Cardiac manifestations of PCOS;
- Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS;
- Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications;
- Had morbid obesity with body mass index (BMI) >35 kg/m2;
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 HydrochlorideMet Group Received metformin hydrochloride 500 mg tab 3 times Daily | Drug | Met Group |
| MI/DCI combination in 40:1 ratioMI-group received MI/DCI combination in 40:1 ratio twice daily | Drug | MI Group |
| Combination of Metformin hydrochloride and MI/DCIMM Group Received both Met and MI Groups Treatment | Drug | MM Group |
Primary outcome
Improvement of mensural pattern
Time frame: 6 months
The Evaluation of the success rate of the applied regimens to gain mensural regular pattern in PCOS Women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin Hydrochloride, MI/DCI combination in 40:1 ratio and Combination of Metformin hydrochloride and MI/DCI in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Zagazig University at 1 site in Egypt.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 20 Dec 2023. 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 Egypt. 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?
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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of mensural pattern (time frame: 6 months). 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 20 Dec 2023.