NCT01896492 (NACIPCOS) is a Phase 4 clinical trial of NAC in PCOS, sponsored by Woman's Health University Hospital, Egypt.

Who is sponsoring NCT01896492?

NCT01896492 is sponsored by Woman's Health University Hospital, Egypt.

What drugs are being tested in NCT01896492?

Interventions in NCT01896492: NAC.

Is NCT01896492 still recruiting?

NCT01896492 is currently completed. Last updated 10 August 2020.

Last reviewed 2020-08-10 · How we verify

NCT01896492: NACIPCOS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clomiphene Citrate Plus N-acetyl Cysteine Versus Clomiphene Citrate for Induction of Ovulation in Women With Newly Diagnosed Polycystic Ovary Syndrome: a Randomized Double-blind Controlled Trial

Completed Phase 4 Last updated 10 August 2020

What this trial tests

Phase 4 trial testing NAC in PCOS in 200 participants. Completed in 1 June 2013.

Timeline

1 January 2011

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Woman's Health University Hospital, Egypt
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	200
Start date	1 January 2011
Primary completion	1 June 2013
Estimated completion	1 June 2013

Drugs / interventions tested

NAC — full drug profile →

Conditions studied

PCOS — all drugs for PCOS →

Sponsor

Woman's Health University Hospital, Egypt

Who can join

Adults 18 to 35, female only, with PCOS. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Ovulation rate
Time frame: 2 years
Clomiphene citrate, 100 mg, was given from day 3 until day 7. In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7. Monitoring of the cycle will involve transvaginal determination of the mean follicular diameter and measurement of serum E2 levels.

Sponsor's own description

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting approximately 6-10% of women of reproductive age. Anovulation, infertility and hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance . Clomiphene citrate remains the standard drug for induction or augmentation of ovulation. However, it is not equally effective in all situations, and therefore it may require additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in PCOS .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Antioxidants for female subfertility.
Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. · · 2020 · cited 82× · PMID 32851663 · DOI 10.1002/14651858.cd007807.pub4

Verify or expand the search:

Other trials of NAC

Trials testing the same drug.

NCT07227649 — NAC-REPAIR for Post-surgical Pain · Phase 2 · not yet recruiting
NCT05509153 — A Randomised Controlled Trial, Of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers · Phase 2 · recruiting
NCT07155044 — A Comparative Study of Neoadjuvant Chemotherapy Versus Upfront Radical Surgery for Upper Tract Urothelial Carcinoma · active not recruiting
NCT06367413 — Effects of Protein and NAC Co-ingestion on Skeletal Muscle Recovery · NA · recruiting
NCT06252519 — Pharmacokinetic Profile of N-Acetyl Cysteine · NA · completed

Other recruiting trials for PCOS

Currently open trials in the same condition.

NCT06424860 — Fish Oil, Metformin and Heart Health in PCOS · Phase 1 · recruiting
NCT06742710 — Liraglutide Treatment in Obese Infertile PCOS Women · Phase 4 · recruiting
NCT07255911 — Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS · NA · recruiting
NCT06793072 — Adipokines in Polycystic Ovary Syndrome · recruiting
NCT06591169 — Lifestyle Changes in PCOS with OSA and NAFLD · NA · recruiting

Other Woman's Health University Hospital, Egypt trials

Trials by the same sponsor.

NCT05771922 — Implication of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies · recruiting
NCT05778279 — Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies · recruiting
NCT05734287 — The Frequency of Polycystic Ovary Syndrome Among Young Reproductive Females Presenting With Hyperandrogenism: a Mixed Co · recruiting
NCT04357054 — Darwish Hysteroscopic Test (Hysteroscopic Bubble Suction and Tubal Peristalsis of Darwish Triad) in Myomatous Uterus · NA · unknown
NCT04825041 — Efficacy of Hysteroscopic Bubble Test, Flow Test and Peristalsis Test. · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01896492 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Woman's Health University Hospital, Egypt
Last refreshed: 10 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01896492.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing