Clomiphene Citrate Plus Cabergoline in Treatment of Polycystic Ovary Syndrome
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 29, 2016
June 1, 2016
1.4 years
October 13, 2015
June 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Size of mature follicles (mm).
1 year
Secondary Outcomes (2)
Number of pregnancy
1 year
Number of mature follicles (mm)
1 year
Study Arms (2)
Clomiphene citrate plus cabergoline
ACTIVE COMPARATORThis 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)
Clomiphene citrate plus placebo
ACTIVE COMPARATORThis 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)
Interventions
50 mg tablet twice daily from the second day of menses to the sixth day
Cabergoline 0.25 mg (half tablet) every 3 days (4 doses).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, 71111, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 13, 2015
First Posted
December 31, 2015
Study Start
May 1, 2015
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
June 29, 2016
Record last verified: 2016-06