Clomiphene Citrate Plus Cabergoline in Treatment of Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT02644304|
Recruitment Status : Recruiting
First Posted : December 31, 2015
Last Update Posted : June 29, 2016
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:
- Oligo- and/or anovulation, (ovulation occurs less than once every 35 days).
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Female Reproductive Problem||Drug: Clomiphene citrate Drug: Cabergoline Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clomiphene Citrate Plus Cabergoline Versus Clomiphene Citrate Alone in Treatment of Polycystic Ovary Syndrome Associated Infertility|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Clomiphene citrate plus cabergoline
This group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus cabergoline 0.25 mg from second day every 3 days (4 doses only)
Drug: Clomiphene citrate
50 mg tablet twice daily from the second day of menses to the sixth dayDrug: Cabergoline
Cabergoline 0.25 mg (half tablet) every 3 days (4 doses).
Active Comparator: Clomiphene citrate plus placebo
This group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus placebo tablets from second day every 3 days (4 doses only)
Drug: Clomiphene citrate
50 mg tablet twice daily from the second day of menses to the sixth dayOther: Placebo
placebo(half tablet) every 3 days (4 doses).
- Size of mature follicles (mm). [ Time Frame: 1 year ]
- Number of pregnancy [ Time Frame: 1 year ]
- Number of mature follicles (mm) [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644304
|Contact: Kamal M Zahran, MDfirstname.lastname@example.org|
|Contact: Mohammed K Ali, MDemail@example.com|
|Assiut, Egypt, 71111|
|Contact: Kamal M Zahran, MD|