PCOSPhase 2NCT03164421
N-Acetylcysteine and L-carnitine in Pcos
A Phase 2 study testing N-Acetylcysteine and L-carnitine in people with PCOS, run by Zagazig University at 1 site in Egypt.
Trial summary
N-Acetylcysteine and L-carnitine were used in pcos patients 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?
- N-Acetylcysteine and L-carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Jul 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
- infertile
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: N-Acetylcysteine Versus L-carnitine in Clomiphene Citrate Resistant Pcos Women. a Randomized Controlled Trial
N-Acetylcysteine and L-carnitine were used in pcos patients
Read the detailed description
N-Acetylcysteine was compared to L-carnitine in clomiphene citrate in Pcos women to detect the hormonal and metabolic effect
- Conditions
- PCOS
- Being tested
- N-Acetylcysteine, L-carnitine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDrug
N-Acetylcysteine in clomiphene resistant pcos women
L-carnitineDrug
Also called motova plus
L-carnitine in clomiphene resistant pcos women
| Study group | Role | What they receive |
|---|---|---|
| N-Acetylcysteine | Experimental | N-Acetylcysteine used by clomiphene resistant pcos women Receives: Drug: N-Acetylcysteine |
| L-carnitine | Active comparator | L-carnitine used by clomiphene resistant pcos women Receives: Drug: L-carnitine |
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 (2)
ovulation rate
number of women with follicle >18mm.
Measured: 3 momths
abortion rate
number of women with abortions
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 posted23 May 2017
- Study startJan 2017
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 164 participants (actual)
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
- NCT03164421
- Sponsor's protocol ID
- ZUH 7
- Status last verified
- Jun 2017
- First submitted
- 21 May 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the collected data willbe available within 6 months
Publications
El Sharkwy IA, Abd El Aziz WM. Randomized controlled trial of N-acetylcysteine versus l-carnitine among women with clomiphene-citrate-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2019 Oct;147(1):59-64. doi: 10.1002/ijgo.12902. Epub 2019 Jul 17.
PubMed 31273783
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-Acetylcysteine Versus L-carnitine in Clomiphene Citrate Resistant Pcos Women. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03164421
- Acronym / sponsor ID
- ZUH 7
- Conditions
- PCOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 23 May 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.
N-Acetylcysteine and L-carnitine were used in pcos patients
Detailed description
N-Acetylcysteine was compared to L-carnitine in clomiphene citrate in Pcos women to detect the hormonal and metabolic effect
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 |
|---|---|---|
| N-Acetylcysteine | Experimental | Drug: N-AcetylcysteineN-Acetylcysteine used by clomiphene resistant pcos women |
| L-carnitine | Active comparator | Drug: L-carnitineL-carnitine used by clomiphene resistant pcos women |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pco
- infertile
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 |
|---|---|---|
| N-AcetylcysteineN-Acetylcysteine in clomiphene resistant pcos women | Drug | N-Acetylcysteine |
| L-carnitineAlso: motova plusL-carnitine in clomiphene resistant pcos women | Drug | L-carnitine |
Primary outcome
pregnancy rate
Time frame: 3 momths
number of women with clinical pregnancy
2 secondary outcomes
ovulation rate
Time frame: 3 momths
abortion rate
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 18 Sep 2018.
- Derived from this study: PubMed 31273783El Sharkwy IA, Abd El Aziz WM. Randomized controlled trial of N-acetylcysteine versus l-carnitine among women with clomiphene-citrate-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2019 Oct;147(1):59-64. doi: 10.1002/ijgo.12902. Epub 2019 Jul 17.
- Individual participant dataSharing planned: Yes. the collected data willbe available within 6 months
Related trials for PCOS
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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.
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 N-Acetylcysteine and L-carnitine 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 2 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 18 Sep 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?
On the ClinicalTrials.gov record for NCT03164421, which also lists 1 linked publication.
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 18 Sep 2018.