PioglitazoneEarly Phase 1NCT03566225
Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome
A Early Phase 1 study testing Pioglitazone, Metformin and Clomiphene Citrate in people with Pioglitazone, run by Ain Shams University at 1 site in Egypt.
Trial summary
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment 1. metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B. 2. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A. 3. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pioglitazone
- What is being tested?
- Pioglitazone, Metformin and Clomiphene Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2018to 30 Mar 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women age 20_35
- BMI 18_29.9
- Women with PCOS(diagnosed by using Rotterdam criteria
- Infertility is cause for seeking tfeatment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
- metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
- pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
- Induction of ovulation by clomiphene citate 50 mg tablets to all participants
Read the detailed description
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
- metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
- pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
- Induction of ovulation by clomiphene citate 50 mg tablets once or twice dialy 12hours apart starting from the 3rd day of menstrual cycle and continue for five days during treatment with insulin sensitizing agents to group A and B.
Participants with oligomenorrhea will recieve two tablets of noreththisterone 5 mg tab every 12 hours for 5 days to allow for withdrawal bleeding before start ovulation induction
- Conditions
- Pioglitazone
- Being tested
- Pioglitazone, Metformin, Clomiphene Citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Glustazon
Insulin sensitizing agents
MetforminDrug
Also called Cidophage
Insulin sensitizing agent
Clomiphene CitrateDrug
Also called Clomid
Induction drug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction Receives: Drug: Pioglitazone; Drug: Clomiphene Citrate |
| Group B | Placebo comparator | Metformin in adose 1500 mg dialy will be administered + clomiphene citrate Receives: Drug: Metformin; Drug: Clomiphene Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Pregnancy rate diagnosed by U/S at five weeks after missed menses
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 posted25 Jun 2018
- Study start30 Jan 2018
- Primary completion28 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PioglitazoneStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelbadea Ali Salih, Ain Shams University
- Investigators
- Asmaa Salih, Resident, Principal investigator, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566225
- Sponsor's protocol ID
- AinShamaU
- Status last verified
- May 2021
- First submitted
- 26 May 2018
- Last updated
- 2 Jun 2021
- 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 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03566225
- Acronym / sponsor ID
- AinShamaU
- Conditions
- Pioglitazone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 25 Jun 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.
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
- metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
- pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
- Induction of ovulation by clomiphene citate 50 mg tablets to all participants
Detailed description
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
- metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
- pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
- Induction of ovulation by clomiphene citate 50 mg tablets once or twice dialy 12hours apart starting from the 3rd day of menstrual cycle and continue for five days during treatment with insulin sensitizing agents to group A and B.
Participants with oligomenorrhea will recieve two tablets of noreththisterone 5 mg tab every 12 hours for 5 days to allow for withdrawal bleeding before start ovulation induction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Pioglitazone, Drug: Clomiphene CitratePioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction |
| Group B | Placebo comparator | Drug: Metformin, Drug: Clomiphene CitrateMetformin in adose 1500 mg dialy will be administered + clomiphene citrate |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women age 20_35
- BMI 18_29.9
- Women with PCOS(diagnosed by using Rotterdam criteria
- Infertility is cause for seeking tfeatment
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PioglitazoneAlso: GlustazonInsulin sensitizing agents | Drug | Group A |
| MetforminAlso: CidophageInsulin sensitizing agent | Drug | Group B |
| Clomiphene CitrateAlso: ClomidInduction drug | Drug | Group A, Group B |
Primary outcome
Clinical pregnancy rate
Time frame: 3 months
Pregnancy rate diagnosed by U/S at five weeks after missed menses
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 2 Jun 2021.
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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.
Asmaa Salih, Resident principal investigator
AinShams University
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 Pioglitazone, Metformin and Clomiphene Citrate in people with Pioglitazone, run by Ain Shams 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 4 inclusion and 5 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 2 Jun 2021. 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. Some participants in this study may receive a placebo. 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?
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?
Clinical pregnancy rate (time frame: 3 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 2 Jun 2021.