Adverse Reaction to Other Drugs and MedicinesPhase 4NCT01957839
Color Doppler Analysıs Of Uterin And Intraovarian Blood Flow Before And After Treatment Wıth Cabergoline In Hyperprolactinemic Patients
A Phase 4 study testing cabergoline treatment in people with Adverse Reaction to Other Drugs and Medicines, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adverse Reaction to Other Drugs and Medicines
- What is being tested?
- cabergoline treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2010to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who had blood prolactin level higher than 25ng/dl
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
the investigators examined the hypothesis that hyperprolactinemia may alter uterin, endometrial and intraovarian blood flow and may contribute to increased infertility by another way.
- Being tested
- cabergoline treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabergoline treatmentDrug
cabergoline treatment for hyperprolactinemia group
| Study group | Role | What they receive |
|---|---|---|
| pretreatment group | No intervention | doppler evaluation at pretreatment period |
| posttreatment group | Experimental | doppler evaluatıon in normoprolactinemia women who given cabergoline treatment Receives: Drug: cabergoline treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
th effect of prolactin vascular flow and resistance
Measured: the effect of prolactin in vascular resistance at 2 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMar 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Reaction to Other Drugs and MedicinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Investigators
- Osman Temizkan, M.D., Principal investigator, SİSLİ ETFAL TEACHİNG HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957839
- Sponsor's protocol ID
- Aşıcıoğlu-08
- Other IDs
- OA8
- Status last verified
- Oct 2013
- First submitted
- 10 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20357175Temizkan 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.
PubMed 25222841
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Doppler Analysıs Of Uterin And Intraovarian Blood Flow Before And After Treatment Wıth Cabergoline In Hyperprolactinemic Patients
- ClinicalTrials.gov ID
- NCT01957839
- Acronym / sponsor ID
- Aşıcıoğlu-08
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the investigators examined the hypothesis that hyperprolactinemia may alter uterin, endometrial and intraovarian blood flow and may contribute to increased infertility by another way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pretreatment group | No intervention | –doppler evaluation at pretreatment period |
| posttreatment group | Experimental | Drug: cabergoline treatmentdoppler evaluatıon in normoprolactinemia women who given cabergoline treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who had blood prolactin level higher than 25ng/dl
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cabergoline treatmentcabergoline treatment for hyperprolactinemia group | Drug | posttreatment group |
Primary outcome
th effect of prolactin vascular flow and resistance
Time frame: the effect of prolactin in vascular resistance at 2 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
- Background: PubMed 20357175Ono 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.
- Derived from this study: PubMed 25222841Temizkan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osman Temizkan, M.D. principal investigator
SİSLİ ETFAL TEACHİNG HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cabergoline treatment in people with Adverse Reaction to Other Drugs and Medicines, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
th effect of prolactin vascular flow and resistance (time frame: the effect of prolactin in vascular resistance at 2 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01957839, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.