HyperprolactinemiaPhase 4NCT00625950
Endometriosis Patients Undergoing Quinagolide Treatment
A Phase 4 study testing ENDOMETRIAL BIOPSY in people with Hyperprolactinemia and Endometriosis, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Dopamine agonists, such as quinagolide, are able to act on the VEGFR-2 blocking antibodies, diminishing Vascular Endothelial Growth Factor effect on angiogenesis in human endometriotic lesions. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Hyperprolactinemia, Endometriosis
- What is being tested?
- ENDOMETRIAL BIOPSY
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2008to May 2008
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hyperprolactinemia
- Unexplained infertility
- Endometriosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Treatment With Agonist Dopaminergics on Endometriosic Lesions.
Dopamine agonists, such as quinagolide, are able to act on the VEGFR-2 blocking antibodies, diminishing Vascular Endothelial Growth Factor effect on angiogenesis in human endometriotic lesions.
- Conditions
- Hyperprolactinemia, Endometriosis
- Being tested
- ENDOMETRIAL BIOPSY
- Keywords
- Hyperprolactinemia, Endometriosis, laparoscopy, angiogenesis, VEGF
- Medical subject headings
- Hyperprolactinemia, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOMETRIAL BIOPSYProcedure or surgery
Two routine laparoscopies in period of three months with endometrial biopsy comparative study performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
observation of three month treatment with Quinagolida in endometriosis patients
Measured: onset and three months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperprolactinemiaStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625950
- Sponsor's protocol ID
- VLC-AP-10208-208-1
- Status last verified
- Jan 2009
- First submitted
- 20 Feb 2008
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gomez R, Abad A, Delgado F, Tamarit S, Simon C, Pellicer A. Effects of hyperprolactinemia treatment with the dopamine agonist quinagolide on endometriotic lesions in patients with endometriosis-associated hyperprolactinemia. Fertil Steril. 2011 Mar 1;95(3):882-8.e1. doi: 10.1016/j.fertnstert.2010.10.024. Epub 2010 Nov 5.
PubMed 21055747
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment With Agonist Dopaminergics on Endometriosic Lesions.
- ClinicalTrials.gov ID
- NCT00625950
- Acronym / sponsor ID
- VLC-AP-10208-208-1
- Conditions
- Hyperprolactinemia, Endometriosis
- Keywords
- Hyperprolactinemia, Endometriosis, laparoscopy, angiogenesis, VEGF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 29 Feb 2008 (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.
Dopamine agonists, such as quinagolide, are able to act on the VEGFR-2 blocking antibodies, diminishing Vascular Endothelial Growth Factor effect on angiogenesis in human endometriotic lesions.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hyperprolactinemia
- Unexplained infertility
- Endometriosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ENDOMETRIAL BIOPSYTwo routine laparoscopies in period of three months with endometrial biopsy comparative study performed. | Procedure or surgery | – |
Primary outcome
observation of three month treatment with Quinagolida in endometriosis patients
Time frame: onset and three months after onset
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 12 Jan 2009.
- Derived from this study: PubMed 21055747Gomez R, Abad A, Delgado F, Tamarit S, Simon C, Pellicer A. Effects of hyperprolactinemia treatment with the dopamine agonist quinagolide on endometriotic lesions in patients with endometriosis-associated hyperprolactinemia. Fertil Steril. 2011 Mar 1;95(3):882-8.e1. doi: 10.1016/j.fertnstert.2010.10.024. Epub 2010 Nov 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ENDOMETRIAL BIOPSY in people with Hyperprolactinemia and Endometriosis, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 3 inclusion and 0 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 12 Jan 2009. 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 Spain. 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?
observation of three month treatment with Quinagolida in endometriosis patients (time frame: onset and three months after onset). 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 NCT00625950, which also lists 1 linked publication.
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 12 Jan 2009.