Polycystic Ovary SyndromeNCT01008046
N-acetyl Cysteine and Clomiphene Citrate or Metformin and Clomiphene Citrate for Women With CC Resistant Polycystic Ovary Syndrome (PCOS).
A study testing combined N-acetyl cysteine -CC and combined metformin-CC in people with Polycystic Ovary Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare and determine the efficacy of combined N-acetyl cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone. Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- combined N-acetyl cysteine -CC and combined metformin-CC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2007to Jun 2009
- Phase
- Interventional
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- CC resistant PCOS
Who cannot join
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals,OB/GYN department
Al Mansurah, Dakahlia Governorate
About this study
Official title: N-acetyl Cysteine Plus Clomiphene Citrate Versus Metformin and Clomiphene Citrate in Treatment of Clomiphene-resistant Polycystic Ovary Syndrome
The purpose of this study is to compare and determine the efficacy of combined N-acetyl cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.
Read the detailed description
In combined NAC-CC group group,patients received NAC (200 mg per sachet, SEDICO, Egypt) for 5-6 weeks from the 1st day of of spontaneous or induced menstruation (in a dose of 1.8 g orally in three divided doses, 3 sachets per dose). All patients in other group received metformin HCl (Cidophage®; Chemical Industries Development, Egypt), 500 mg thrice daily for 5-6 weeks from the 1st day of spontaneous or induced menstruation. Then after the end of this period, patients in either group received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation, it was increased by 50 mg for the next cycle. Patients continued treatment for three successive cycles using the same protocol. NAC and metformin were stopped only when pregnancy was documented.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- combined N-acetyl cysteine -CC, combined metformin-CC
- Keywords
- Polycystic ovary syndrome, clomiphene resistance, metformin, N-acetyl cysteine
- 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.
combined N-acetyl cysteine -CCDrug
N-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles
combined metformin-CCDrug
Patients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles
| Study group | Role | What they receive |
|---|---|---|
| combined N-acetyl cysteine - CC | Experimental | N-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles Receives: Drug: combined N-acetyl cysteine -CC |
| combined metformin-CC | Active comparator | Patients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles. Receives: Drug: combined metformin-CC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Secondary outcomes (1)
pregnancy rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startApr 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- Hatem Abu Hashim, MD. MRCOG, Principal investigator, Mansoura University HospitalKamal Anwar, MD, Study chair, Mansoura University HospitalRafat Abd El-Fatah, MD, Study director, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008046
- Sponsor's protocol ID
- MU- 183
- Other IDs
- FMH-112-M
- Status last verified
- Nov 2009
- First submitted
- 4 Nov 2009
- Last updated
- 5 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elnashar A, Fahmy M, Mansour A, Ibrahim K. N-acetyl cysteine vs. metformin in treatment of clomiphene citrate-resistant polycystic ovary syndrome: a prospective randomized controlled study. Fertil Steril. 2007 Aug;88(2):406-9. doi: 10.1016/j.fertnstert.2006.11.173. Epub 2007 Mar 1.
PubMed 17335818Rizk AY, Bedaiwy MA, Al-Inany HG. N-acetyl-cysteine is a novel adjuvant to clomiphene citrate in clomiphene citrate-resistant patients with polycystic ovary syndrome. Fertil Steril. 2005 Feb;83(2):367-70. doi: 10.1016/j.fertnstert.2004.07.960.
PubMed 15705376Siebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.
PubMed 17007847
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetyl Cysteine Plus Clomiphene Citrate Versus Metformin and Clomiphene Citrate in Treatment of Clomiphene-resistant Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01008046
- Acronym / sponsor ID
- MU- 183
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovary syndrome, clomiphene resistance, metformin, N-acetyl cysteine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Nov 2009 (estimated)
- 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.
The purpose of this study is to compare and determine the efficacy of combined N-acetyl cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.
Detailed description
In combined NAC-CC group group,patients received NAC (200 mg per sachet, SEDICO, Egypt) for 5-6 weeks from the 1st day of of spontaneous or induced menstruation (in a dose of 1.8 g orally in three divided doses, 3 sachets per dose). All patients in other group received metformin HCl (Cidophage®; Chemical Industries Development, Egypt), 500 mg thrice daily for 5-6 weeks from the 1st day of spontaneous or induced menstruation. Then after the end of this period, patients in either group received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation, it was increased by 50 mg for the next cycle. Patients continued treatment for three successive cycles using the same protocol. NAC and metformin were stopped only when pregnancy was documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined N-acetyl cysteine - CC | Experimental | Drug: combined N-acetyl cysteine -CCN-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles |
| combined metformin-CC | Active comparator | Drug: combined metformin-CCPatients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles. |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CC resistant PCOS
Key exclusion criteria (3 listed)
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
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 |
|---|---|---|
| combined N-acetyl cysteine -CCN-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles | Drug | combined N-acetyl cysteine - CC |
| combined metformin-CCPatients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles | Drug | combined metformin-CC |
Primary outcome
Ovulation rate
1 secondary outcome
pregnancy rate
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 5 Nov 2009.
- Background: PubMed 17335818Elnashar A, Fahmy M, Mansour A, Ibrahim K. N-acetyl cysteine vs. metformin in treatment of clomiphene citrate-resistant polycystic ovary syndrome: a prospective randomized controlled study. Fertil Steril. 2007 Aug;88(2):406-9. doi: 10.1016/j.fertnstert.2006.11.173. Epub 2007 Mar 1.
- Background: PubMed 15705376Rizk AY, Bedaiwy MA, Al-Inany HG. N-acetyl-cysteine is a novel adjuvant to clomiphene citrate in clomiphene citrate-resistant patients with polycystic ovary syndrome. Fertil Steril. 2005 Feb;83(2):367-70. doi: 10.1016/j.fertnstert.2004.07.960.
- Background: PubMed 17007847Siebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.
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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.
Hatem Abu Hashim, MD. MRCOG principal investigator
Mansoura University Hospital
Kamal Anwar, MD study chair
Mansoura University Hospital
Rafat Abd El-Fatah, MD study director
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined N-acetyl cysteine -CC and combined metformin-CC in people with Polycystic Ovary Syndrome, run by Mansoura 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 1 inclusion and 3 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 5 Nov 2009. 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.
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?
Ovulation rate. 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 NCT01008046, which also lists 3 linked publications.
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 5 Nov 2009.