Clomiphene Citrate Plus Cabergoline in Treatment of Polycystic Ovary Syndrome

Female Reproductive Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02644304
• Other study ID #: CC in PCOS
• Status: Recruiting
• Phase: Phase 2
• First received: October 13, 2015
• Last updated: June 28, 2016
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Woman's Health University Hospital, Egypt
• Contact: Kamal M Zahran, MD
• Phone: +20882414616
• Email: drzahranmk[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Faculty of Medicine, Assiut University.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Reproductive Problem
• Polycystic Ovary Syndrome

Intervention

Drug:
• Clomiphene citrate
50 mg tablet twice daily from the second day of menses to the sixth day
• Cabergoline
Cabergoline 0.25 mg (half tablet) every 3 days (4 doses).

Other:
• Placebo
placebo(half tablet) every 3 days (4 doses).

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of mature follicles (mm).		1 year	Yes
Secondary	Number of pregnancy		1 year	Yes
Secondary	Number of mature follicles (mm)		1 year	Yes