PCOSPhase 2NCT03108963
L-carnitine and Metformin in Obese PCOS Women.
A Phase 2 study testing L-carnitine and Metformin in people with PCOS, run by Zagazig University at 1 site in Egypt.
Trial summary
L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effect: a randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- L-carnitine and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Mar 2018
- Phase
- Phase 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- pco
- obese
- ifertile
Who cannot join
- no medical disorders
- no hormonal treatment in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L-carnitine Plus Metformin in Clomiphene-resistant Obese PCOS Women, Reproductive and Metabolic Effects: a Randomized Clinical Trial
L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effect: a randomized clinical trial
Read the detailed description
the trial aims to compare L-carnitine and plus metformin in clomiphene-resistant obese PCOS women with placebo to state the reproductive and metabolic effects in form of pregnancy and insulin resistance parameters and lipid metabolism.
- Conditions
- PCOS
- Being tested
- L-carnitine and Metformin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitine and MetforminDrug
Also called motova plus and glucphage
L-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.
placeboDrug
placebo was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.
| Study group | Role | What they receive |
|---|---|---|
| L-carnitine and Metformin | Experimental | L-carnitine and Metformin in Obese PCOS Women trying induction of ovulation with clomiphene citrate. Receives: Drug: L-carnitine and Metformin |
| placebo | Active comparator | placebo was given toObese PCOS Women trying induction of ovulation with clomiphene citrate. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
number of women with clinical pregnancy
Measured: 3 momths
Secondary outcomes (4)
ovulation rate
number of women with follicle >18mm.
Measured: 3 momths
abortion rate
number of women with abortions
Measured: 3 momths
insulin resistance
fasting glucose and insulin
Measured: 3 momths
lipid metabolism
Triglyceride, cholesterol
Measured: 3 momths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startJan 2017
- Primary completionMar 2018
- Study completionMar 2018
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IBRAHIM ABD ELGAFOR, Zagazig University
- Investigators
- ibrahim A el sharkwy, MD, Principal investigator, FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108963
- Sponsor's protocol ID
- ZUH 6
- Status last verified
- Apr 2017
- First submitted
- 6 Apr 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-carnitine Plus Metformin in Clomiphene-resistant Obese PCOS Women, Reproductive and Metabolic Effects: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03108963
- Acronym / sponsor ID
- ZUH 6
- Conditions
- PCOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Apr 2017 (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.
L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effect: a randomized clinical trial
Detailed description
the trial aims to compare L-carnitine and plus metformin in clomiphene-resistant obese PCOS women with placebo to state the reproductive and metabolic effects in form of pregnancy and insulin resistance parameters and lipid metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-carnitine and Metformin | Experimental | Drug: L-carnitine and MetforminL-carnitine and Metformin in Obese PCOS Women trying induction of ovulation with clomiphene citrate. |
| placebo | Active comparator | Drug: placeboplacebo was given toObese PCOS Women trying induction of ovulation with clomiphene citrate. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pco
- obese
- ifertile
Key exclusion criteria (2 listed)
- no medical disorders
- no hormonal treatment in the previous 3 months
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 |
|---|---|---|
| L-carnitine and MetforminAlso: motova plus and glucphageL-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate. | Drug | L-carnitine and Metformin |
| placeboplacebo was given Obese PCOS Women trying induction of ovulation with clomiphene citrate. | Drug | placebo |
Primary outcome
pregnancy rate
Time frame: 3 momths
number of women with clinical pregnancy
4 secondary outcomes
ovulation rate
Time frame: 3 momths
abortion rate
Time frame: 3 momths
insulin resistance
Time frame: 3 momths
lipid metabolism
Time frame: 3 momths
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 May 2018.
- Individual participant dataSharing planned: No
Related trials for PCOS
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
ibrahim A el sharkwy, MD principal investigator
FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-carnitine and Metformin in people with PCOS, 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 3 inclusion and 2 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 May 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 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 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?
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?
pregnancy rate (time frame: 3 momths). 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 May 2018.