Color Doppler Analysıs Of Uterin And Intraovarian Blood Flow Before And After Treatment Wıth Cabergoline In Hyperprolactinemic Patients

Adverse Reaction to Other Drugs and Medicines Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957839
• Other study ID #: Asicioglu-08
• Secondary ID: OA8
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2013
• Last updated: October 7, 2013
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2013
• Source: Istanbul Bakirkoy Maternity and Children Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: turkey:turkey healty ministryUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

the investigators examined the hypothesis that hyperprolactinemia may alter uterin, endometrial and intraovarian blood flow and may contribute to increased infertility by another way.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women who had blood prolactin level higher than 25ng/dl

Exclusion Criteria:

• Pregnancy

• Use of drugs effecting vasculature such as hormonal therapy, oral contraceptives, antihypertensives

• Diseases like pelvic inflammatory disease and systemic hypertension

• Women with clinically overt or treated cardiovascular disease

• Concurrent illness other than hyperprolactinemia

Study Design

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

Related Conditions & MeSH terms

• Adverse Reaction to Other Drugs and Medicines

Intervention

Drug:
• cabergoline treatment
cabergoline treatment for hyperprolactinemia group

Locations

Country	Name	City	State
Turkey	Sisli Etfal Teaching Hosital	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Bakirkoy Maternity and Children Diseases Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ono M, Miki N, Amano K, Kawamata T, Seki T, Makino R, Takano K, Izumi S, Okada Y, Hori T. Individualized high-dose cabergoline therapy for hyperprolactinemic infertility in women with micro- and macroprolactinomas. J Clin Endocrinol Metab. 2010 Jun;95(6):2672-9. doi: 10.1210/jc.2009-2605. Epub 2010 Mar 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	th effect of prolactin vascular flow and resistance		the effect of prolactin in vascular resistance at 2 weeks after treatment	Yes