E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Luteolisis o regresión del cuerpo lúteo. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011117 |
E.1.2 | Term | Corpus luteum cyst or haematoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Estudiar la inducción de la luteolisis mediante determinaciones séricas de progesterona y la vascularización del cuerpo lúteo con Doppler en mujeres en edad reproductiva que presenten un cuerpo lúteo hemorrágico con el fin de producir una mejoría clínica del dolor, la hemorragia y la estancia hospitalaria en aquellas mujeres con folículo roto. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Mujeres en edad reproductiva que acudan al servicio de urgencias del Hospital universitario Dr. Peset por dolor en hemiabdomen inferior y al ser atendidas exista una sospecha clínica/ecográfica de que se trate de un cuerpo lúteo hemorrágico vs roto -Ciclos menstruales regulares (28 ±7 dias ) -Ínice de masa corporal normal ≤ 30 -TIG: negativo
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E.4 | Principal exclusion criteria |
-Edad no reproductiva -Embarazo -Haber recibido cualquier tipo de tratamiento hormonal que pudiese influir en la evolución del ciclo ovárico: anticonceptivos hormonales, análogos de la GnRH, progestágenos y Danazol -Alteraciones moderadas o severas de la función renal y/o hepática -Prolemas alérgicos graves -Hipersensibilidad al principio activo análogo
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E.5 End points |
E.5.1 | Primary end point(s) |
-Antecedentes médicos y quirúrgicos -Historia obstétrica (paridad) -Historia ginecológica (Fecha de última regla, fórmula menstrual) -Edad -Tratamientos previos empleados: hormonales o cirugía -Descripción de hallazgos clínicos (sintomatología: infertilidad, dismenorrea, dispareunia, disquecia) -Realizar escala del dolor -Hallazgos ecográficos. -Determinaciones analíticas y hormonales: extracción de hemograma, hemostasia y bioquímica al ingreso; hemograma diario para valorar variaciones en el hematocrito y el hemograma; toma de muestra para estudio hormonal posteriro (progesterona, estradiol, FSH, LH; inhibina A) -Días de estancia hospitalaria
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
ensayo clínico randomizado |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |