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Clomiphene Citrate Plus Cabergoline in Treatment of Polycystic Ovary Syndrome

This study is currently recruiting participants.
Verified June 2016 by Kamal Mohamed Zahran, Woman's Health University Hospital, Egypt
Sponsor:
ClinicalTrials.gov Identifier:
NCT02644304
First Posted: December 31, 2015
Last Update Posted: June 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kamal Mohamed Zahran, Woman's Health University Hospital, Egypt
  Purpose

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.


Condition Intervention Phase
Female Reproductive Problem Drug: Clomiphene citrate Drug: Cabergoline Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clomiphene Citrate Plus Cabergoline Versus Clomiphene Citrate Alone in Treatment of Polycystic Ovary Syndrome Associated Infertility

Resource links provided by NLM:


Further study details as provided by Kamal Mohamed Zahran, Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • Size of mature follicles (mm). [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Number of pregnancy [ Time Frame: 1 year ]
  • Number of mature follicles (mm) [ Time Frame: 1 year ]

Estimated Enrollment: 88
Study Start Date: May 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 day
Drug: 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 day
Other: Placebo
placebo(half tablet) every 3 days (4 doses).

  Eligibility

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644304


Contacts
Contact: Kamal M Zahran, MD +20882414616 drzahranmk@gmail.com
Contact: Mohammed K Ali, MD +20882414621 m_khairy2001@yahoo.com

Locations
Egypt
Assiut university Recruiting
Assiut, Egypt, 71111
Contact: Kamal M Zahran, MD         
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
  More Information

Responsible Party: Kamal Mohamed Zahran, Dr, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT02644304     History of Changes
Other Study ID Numbers: CC in PCOS
First Submitted: October 13, 2015
First Posted: December 31, 2015
Last Update Posted: June 29, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Cabergoline
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Antineoplastic Agents
Antiparkinson Agents