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Contraceptive-controlled study to evaluate the effect on nerve fibers in patients diagnosed with endometriosis grade III / IV symptomatic ascending-dose oral quinagolide for 16 weeks

Double-blind, randomized, controlled contraceptives, parallel group, to assess the effect on nerve fibers in patients diagnosed with endometriosis grade III / IV symptomatic ascending-dose oral quinagolide for 16 weeks

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001789-13-ES
Enrollment
Unknown
Registered
2012-09-14
Start date
2012-11-16
Completion date
Unknown
Last updated
2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis grade III/IV

Interventions

Trade Name: Norprolac 25 microgramos y 50 microgramos comprimidos Product Name: QUINAGOLIDE Pharmaceutical Form: Tablet INN or Proposed INN: QUINAGOLIDE HYDROCHLORIDE CAS Number: 94424-50-7 Concentrat

Sponsors

Instituto de Investigacion Sanitaria La e
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with endometriosis grade III / IV diagnosed by history, physical examination and complementary examinations: ECO TV. ECO TR. RMN. Pain resistant to medical treatment: VAS greater than 50 Indication for surgery No immediate desire for pregnancy Women over 18 Washing period of hormone treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Be subjected to treatment with contraceptives, hormone replacement therapy or other treatment for endometriosis Tolerability and pharmacokinetics studies Intolerance or allergy to quinagolide or any of the excipients Rejection of barrier contraception during study Contraindication surgery History of surgery for endometriosis

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of quinagolide on symptoms and nerve fiber density in patients with endometrial level endometriosis grade III / IV symptomatic as an alternative to surgery.;Secondary Objective: 1) Evaluation by visual analogue scale the effect of quinagolide on pain in patients with endometriosis stage III / IV. 2) evaluate through questionnaires on quality of life, the effect of quinagolide in patients with endometriosis stage III / IV. 3) Determine the effect on peripheral blood of quinagolide on Profile of coagulation / fibrinolysis circulating prolactin levels;Primary end point(s): Nerve fiber density;Timepoint(s) of evaluation of this end point: Completion of the study—

Secondary

MeasureTime frame
Secondary end point(s): Pain- quality of life.;Timepoint(s) of evaluation of this end point: In each study visit.—

Countries

Spain

Contacts

Public ContactUREC

Instituto de Investigacion Sanitaria La e

investigacion_clinica@iislafe.es34963862458

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026