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

• Sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01957839
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Reaction to Other Drugs and Medicines	Drug: cabergoline treatment	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: pretreatment group doppler evaluation at pretreatment period
Experimental: posttreatment group doppler evaluatıon in normoprolactinemia women who given cabergoline treatment	Drug: cabergoline treatment; cabergoline treatment for hyperprolactinemia group

Outcome Measures

Primary Outcome Measures

1. th effect of prolactin vascular flow and resistance [the effect of prolactin in vascular resistance at 2 weeks after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sisli Etfal Teaching Hosital	Sisli		Turkey

Sponsors and Collaborators

• Istanbul Bakirkoy Maternity and Children Diseases Hospital

Investigators

• Principal Investigator: Osman Temizkan, M.D., SİSLİ ETFAL TEACHİNG HOSPİTAL

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Osman Aşıcıoğlu, sisli etfal teaching hospital department gynecology and obstetric, Istanbul Bakirkoy Maternity and Children Diseases Hospital
• ClinicalTrials.gov Identifier: NCT01957839
• Other Study ID Numbers: Aşıcıoğlu-08; OA8
• First Posted: Oct 8, 2013
• Last Update Posted: Oct 8, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Cabergoline

Study Results

No Results Posted as of Oct 8, 2013