NCT01957839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

1.4 years

First QC Date

September 10, 2013

Last Update Submit

October 7, 2013

Conditions

Adverse Reaction to Other Drugs and Medicines

Outcome Measures

Primary Outcomes (1)

  • th effect of prolactin vascular flow and resistance

    the effect of prolactin in vascular resistance at 2 weeks after treatment

Study Arms (2)

pretreatment group

NO INTERVENTION

doppler evaluation at pretreatment period

posttreatment group

EXPERIMENTAL

doppler evaluatıon in normoprolactinemia women who given cabergoline treatment

Drug: cabergoline treatment

Interventions

cabergoline treatmentDRUG

cabergoline treatment for hyperprolactinemia group

posttreatment group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Teaching Hosital

Şişli, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 20357175BACKGROUND

  • Temizkan O, Temizkan S, Asicioglu O, Aydin K, Kucur S. Color Doppler analysis of uterine, spiral, and intraovarian artery blood flow before and after treatment with cabergoline in hyperprolactinemic patients. Gynecol Endocrinol. 2015 Jan;31(1):75-8. doi: 10.3109/09513590.2014.958989. Epub 2014 Sep 15.

    PMID: 25222841DERIVED

Study Officials

  • Osman Temizkan, M.D.

    SİSLİ ETFAL TEACHİNG HOSPİTAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
sisli etfal teaching hospital department gynecology and obstetric

Study Record Dates

First Submitted

September 10, 2013

First Posted

October 8, 2013

Study Start

March 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

TU(1)