Skip to content

Clomiphene Citrate Plus Cabergoline in Treatment of Polycystic Ovary Syndrome

Clomiphene Citrate Plus Cabergoline Versus Clomiphene Citrate Alone in Treatment of Polycystic Ovary Syndrome Associated Infertility

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02644304
Enrollment
88
Registered
2015-12-31
Start date
2015-05-31
Completion date
2016-12-31
Last updated
2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Reproductive Problem

Brief summary

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged women and affects approximately 5-12 % of the female population. In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected individuals must have two out of the following three criteria: 1. Oligo- and/or anovulation, (ovulation occurs less than once every 35 days). 2. Hyperandrogenism, clinical signs include hirsutism, acne, alopecia, and frank virilization, while chemical indicators include raised concentrations of total testosterone and androstenedione , and elevated free androgen index. 3. Polycystic ovaries on sonographic examination, presence of 12 or more follicles in either ovary measuring 2-9 mm in diameter, increased ovarian volume more than 10 cm3 and/or increase in stromal echogenicity. Clearly, according to the Rotterdam diagnostic criteria, the majority of women with PCOS can be diagnosed without the need of laboratory examinations. Clomiphene citrate (CC) is still the first-line medication for the induction of ovulation. It is an anti-estrogenic compound made up of two isomers, enclomiphene and zuclomiphene; the latter being the more potent of the two. It is a non-steroidal compound closely resembling estrogen. CC acts by blocking estrogen receptors, particularly in the hypothalamus, thereby signaling a lack of circulating estrogens and inducing a change in the pulsatile release of gonadotrophin-releasing hormone (GnRH). This induces release of follicle stimulating hormone from the anterior pituitary and is often enough to set the cycle of events leading to ovulation into motion. Cabergoline, ergot-derived dopamine agonists with a very long half life, is an effective prolactin suppressor. Cabergoline oral administration contains a weekly dose of 0.5 - 3 mg, which could be increased, if needed, to twice a week. This medicine has slight dopamine agonistic side effects, headache being the most common one. Treatment in the very beginning should start with a partial dose (half a pill) at bedtime with a small amount of food. Low incidence of side effects and its weekly dose has made Cabergoline a choice drug for treatment of related diseases.

Interventions

DRUGClomiphene citrate

50 mg tablet twice daily from the second day of menses to the sixth day

DRUGCabergoline

Cabergoline 0.25 mg (half tablet) every 3 days (4 doses).

OTHERPlacebo

placebo(half tablet) every 3 days (4 doses).

Sponsors

Woman's Health University Hospital, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 2 or more of PCOS signs according to Rotterdam diagnostic criteria (2003).- * Primary or secondary infertility.- * Absence of galactorrhoea * Normal serum prolactin or slightly elevated (up to 50 ng/dl) * Normal hysterosalpingography * Normal spermogram

Exclusion criteria

* Women on other line of treatment as aromatase inhibitors, gonadotrophins, or tamoxifen. * Known hypersensitivity for Clomiphene citrate or cabergoline. * Other factors of infertility as tubal factor, uterine factor or male factor.

Design outcomes

Primary

MeasureTime frame
Size of mature follicles (mm).1 year

Secondary

MeasureTime frame
Number of pregnancy1 year
Number of mature follicles (mm)1 year

Countries

Egypt

Contacts

Primary ContactKamal M Zahran, MD
drzahranmk@gmail.com+20882414616
Backup ContactMohammed K Ali, MD
m_khairy2001@yahoo.com+20882414621

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026