Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

13 juin 2013 mis à jour par: Teva Women's Health

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Aperçu de l'étude

Statut

Complété

Les conditions

Prévention de la grossesse

Intervention / Traitement

Médicament: DR-103

Type d'étude

Interventionnel

Inscription (Réel)

3597

Phase

Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- Alabama
  - Montgomery, Alabama, États-Unis, 36116
    - Teva Women's Health Research Investigational Site
- Arizona
  - Phoenix, Arizona, États-Unis, 85015
    - Teva Women's Health Research Investigational Site
  - Phoenix, Arizona, États-Unis, 85037
    - Teva Women's Health Research Investigational Site
  - Tucson, Arizona, États-Unis, 85741
    - Teva Women's Health Research Investigational Site
- Arkansas
  - Little Rock, Arkansas, États-Unis, 72205
    - Teva Women's Health Research Investigational Site
- California
  - Anaheim, California, États-Unis, 92801
    - Teva Women's Health Research Investigational Site
  - Irvine, California, États-Unis, 92618
    - Teva Women's Health Research Investigational Site
  - Los Angeles, California, États-Unis, 90033
    - Teva Women's Health Research Investigational Site
  - National City, California, États-Unis, 91950
    - Teva Women's Health Research Investigational Site
  - San Diego, California, États-Unis, 29103
    - Teva Women's Health Research Investigational Site
  - San Diego, California, États-Unis, 92108
    - Teva Women's Health Research Investigational Site
  - San Diego, California, États-Unis, 92123
    - Teva Women's Health Research Investigational Site
  - San Francisco, California, États-Unis, 92103
    - Teva Women's Health Research Investigational Site
  - Torrance, California, États-Unis, 90502
    - Teva Women's Health Research Investigational Site
- Colorado
  - Colorado Springs, Colorado, États-Unis, 80909
    - Teva Women's Health Research Investigational Site
  - Pueblo, Colorado, États-Unis, 81001
    - Teva Women's Health Research Investigational Site
- District of Columbia
  - Washington, District of Columbia, États-Unis, 20036
    - Teva Women's Health Research Investigational Site
- Florida
  - Clearwater, Florida, États-Unis, 33759
    - Teva Women's Health Research Investigational Site
  - Jacksonville, Florida, États-Unis, 32207
    - Teva Women's Health Research Investigational Site
  - Leesburg, Florida, États-Unis, 34748
    - Teva Women's Health Research Investigational Site
  - Miami, Florida, États-Unis, 33143
    - Teva Women's Health Research Investigational Site
  - Miami, Florida, États-Unis, 33186
    - Teva Women's Health Research Investigational Site
  - New Port Richey, Florida, États-Unis, 34652
    - Teva Women's Health Research Investigational Site
  - Palm Beach, Florida, États-Unis, 33409
    - Teva Women's Health Research Investigational Site
  - St. Petersburg, Florida, États-Unis, 33709
    - Teva Women's Health Research Investigational Site
  - Tampa, Florida, États-Unis, 33613
    - Teva Women's Health Research Investigational Site
  - West Palm Beach, Florida, États-Unis, 33401
    - Teva Women's Health Research Investigational Site
- Georgia
  - Atlanta, Georgia, États-Unis, 30303
    - Teva Women's Health Research Investigational Site
  - Decatur, Georgia, États-Unis, 30034
    - Teva Women's Health Research Investigational Site
  - Roswell, Georgia, États-Unis, 30075
    - Teva Women's Health Research Investigational Site
  - Sandy Springs, Georgia, États-Unis, 30328
    - Teva Women's Health Research Investigational Site
  - Savannah, Georgia, États-Unis, 31406
    - Teva Women's Health Research Investigational Site
- Idaho
  - Meridian, Idaho, États-Unis, 83642
    - Teva Women's Health Research Investigational Site
- Illinois
  - Champaign, Illinois, États-Unis, 61820
    - Teva Women's Health Research Investigational Site
- Kansas
  - Wichita, Kansas, États-Unis, 67207
    - Teva Women's Health Research Investigational Site
- Kentucky
  - Lexington, Kentucky, États-Unis, 40509
    - Teva Women's Health Research Investigational Site
  - Louisville, Kentucky, États-Unis, 40291
    - Teva Women's Health Research Investigational Site
  - Mt Sterling, Kentucky, États-Unis, 40353
    - Teva Women's Health Research Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, États-Unis, 70808
    - Teva Women's Health Research Investigational Site
  - Metairie, Louisiana, États-Unis, 70006
    - Teva Women's Health Research Investigational Site
- Maryland
  - Baltimore, Maryland, États-Unis, 21201
    - Teva Women's Health Research Investigational Site
- Missouri
  - Kansas City, Missouri, États-Unis, 64108
    - Teva Women's Health Research Investigational Site
  - St. Louis, Missouri, États-Unis, 63117
    - Teva Women's Health Research Investigational Site
- Nebraska
  - Lincoln, Nebraska, États-Unis, 68510
    - Teva Women's Health Research Investigational Site
- Nevada
  - Las Vegas, Nevada, États-Unis, 89146
    - Teva Women's Health Research Investigational Site
- New Jersey
  - Berlin, New Jersey, États-Unis, 08009
    - Teva Women's Health Research Investigational Site
  - Lawrenceville, New Jersey, États-Unis, 08648
    - Teva Women's Health Research Investigational Site
  - Moorestown, New Jersey, États-Unis, 08057
    - Teva Women's Health Research Investigational Site
  - New Brunswick, New Jersey, États-Unis, 08901
    - Teva Women's Health Research Investigational Site
- New Mexico
  - Albuquerque, New Mexico, États-Unis, 87102
    - Teva Women's Health Research Investigational Site
- New York
  - Port Jefferson, New York, États-Unis, 11777
    - Teva Women's Health Research Investigational Site
  - Rochester, New York, États-Unis, 14609
    - Teva Women's Health Research Investigational Site
- North Carolina
  - Cary, North Carolina, États-Unis, 27518
    - Teva Women's Health Research Investigational Site
  - Charlotte, North Carolina, États-Unis, 28209
    - Teva Women's Health Research Investigational Site
  - New Bern, North Carolina, États-Unis, 28562
    - Teva Women's Health Research Investigational Site
  - Raleigh, North Carolina, États-Unis, 27609
    - Teva Women's Health Research Investigational Site
  - Raleigh, North Carolina, États-Unis, 27612
    - Teva Women's Health Research Investigational Site
  - Salisbury, North Carolina, États-Unis, 28144
    - Teva Women's Health Research Investigational Site
  - Wilmington, North Carolina, États-Unis, 28401
    - Teva Women's Health Research Investigational Site
  - Winston-Salem, North Carolina, États-Unis, 27103
    - Teva Women's Health Research Investigational Site
- Ohio
  - Columbus, Ohio, États-Unis, 43210
    - Teva Women's Health Research Investigational Site
  - Columbus, Ohio, États-Unis, 43213
    - Teva Women's Health Research Investigational Site
- Oklahoma
  - Edmond, Oklahoma, États-Unis, 73013
    - Teva Women's Health Research Investigational Site
  - Oklahoma City, Oklahoma, États-Unis, 73112
    - Teva Women's Health Research Investigational Site
- Oregon
  - Eugene, Oregon, États-Unis, 97401
    - Teva Women's Health Research Investigational Site
  - Medford, Oregon, États-Unis, 97504
    - Teva Women's Health Research Investigational Site
- Pennsylvania
  - Philadelphia, Pennsylvania, États-Unis, 19114
    - Teva Women's Health Research Investigational Site
  - Pittsburgh, Pennsylvania, États-Unis, 15206
    - Teva Women's Health Research Investigational Site
- South Carolina
  - Charleston, South Carolina, États-Unis, 29425
    - Teva Women's Health Research Investigational Site
  - Columbia, South Carolina, États-Unis, 29201
    - Teva Women's Health Research Investigational Site
  - Goose Creek, South Carolina, États-Unis, 29445
    - Teva Women's Health Research Investigational Site
  - Greenville, South Carolina, États-Unis, 29605
    - Teva Women's Health Research Investigational Site
  - Greer, South Carolina, États-Unis, 29651
    - Teva Women's Health Research Investigational Site
  - Hilton Head Island, South Carolina, États-Unis, 29926
    - Teva Women's Health Research Investigational Site
- Tennessee
  - Bristol, Tennessee, États-Unis, 37620
    - Teva Women's Health Research Investigational Site
  - Jackson, Tennessee, États-Unis, 38305
    - Teva Women's Health Research Investigational Site
  - Knoxville, Tennessee, États-Unis, 37920
    - Teva Women's Health Research Investigational Site
  - Memphis, Tennessee, États-Unis, 38120
    - Teva Women's Health Research Investigational Site
  - Nashville, Tennessee, États-Unis, 37203
    - Teva Women's Health Research Investigational Site
- Texas
  - Austin, Texas, États-Unis, 78759
    - Teva Women's Health Research Investigational Site
  - Dallas, Texas, États-Unis, 75234
    - Teva Women's Health Research Investigational Site
  - Dallas, Texas, États-Unis, 75390
    - Teva Women's Health Research Investigational Site
  - Ft. Worth, Texas, États-Unis, 76135
    - Teva Women's Health Research Investigational Site
  - Houston, Texas, États-Unis, 77054
    - Teva Women's Health Research Investigational Site
  - San Antonio, Texas, États-Unis, 78229
    - Teva Women's Health Research Investigational Site
  - Waco, Texas, États-Unis, 76712
    - Teva Women's Health Research Investigational Site
- Utah
  - Salt Lake City, Utah, États-Unis, 84107
    - Teva Women's Health Research Investigational Site
- Virginia
  - Arlington, Virginia, États-Unis, 22203
    - Teva Women's Health Research Investigational Site
  - Newport News, Virginia, États-Unis, 23602
    - Teva Women's Health Research Investigational Site
  - Norfolk, Virginia, États-Unis, 23502
    - Teva Women's Health Research Investigational Site
  - Norfolk, Virginia, États-Unis, 23507
    - Teva Women's Health Research Investigational Site
  - Richmond, Virginia, États-Unis, 23233
    - Teva Women's Health Research Investigational Site
- Washington
  - Seattle, Washington, États-Unis, 98105
    - Teva Women's Health Research Investigational Site
  - Tacoma, Washington, États-Unis, 98405
    - Teva Women's Health Research Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 40 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

Sexually active at risk for pregnancy
Agreement to use study OC therapy as their only method of birth control during the study
history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
Others as dictated by FDA-approved protocol

Exclusion Criteria:

Any contraindication to the use of oral contraceptives
Pregnancy or plans to become pregnant in the next 14 months
Smoker and age ≥ 35 years
Others as dictated by FDA-approved protocol

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: La prévention
Répartition: N / A
Modèle interventionnel: Affectation à un seul groupe
Masquage: Aucun (étiquette ouverte)

Nombre de bras

Armes et Interventions

Groupe de participants / Bras	Intervention / Traitement
Expérimental: DR-103 Four 91-day cycles of the DR-103 regimen: 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.	Médicament: DR-103 One tablet daily. Four 91-day cycles of the DR-103 regimen: 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE. Autres noms: lévonorgestrel/éthinylestradiol Quartette®

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight Délai: Day 1 up to year 1	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)(total number of pregnancies)(4)/(total number of 91-day cycles)	Day 1 up to year 1
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight Délai: Day 1 up to year 1	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)(total number of pregnancies)(4)/(total number of 91-day cycles)	Day 1 up to year 1
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight Délai: Day 1 up to year 1	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)(total number of pregnancies)(4)/(total number of 91-day cycles)	Day 1 up to year 1
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight Délai: Day 1 up to year 1	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)(total number of pregnancies)(13)/(total number of 28-day cycles)	Day 1 up to year 1
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight Délai: Day 1 up to year 1	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)(total number of pregnancies)(13)/(total number of 28-day cycles)	Day 1 up to year 1
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight Délai: Day 1 up to year 1	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)(total number of pregnancies)(13)/(total number of 28-day cycles)	Day 1 up to year 1
Summary of Participants With Treatment-emergent Adverse Events Délai: Day 1 up to 13 months	The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date. Relationship to study drug was assessed by the investigator. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention.	Day 1 up to 13 months

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight Délai: Day 1 up to year 1	A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.	Day 1 up to year 1
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight Délai: Day 1 up to year 1	A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.	Day 1 up to year 1

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Teva Women's Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2009

Achèvement primaire (Réel)

1 septembre 2011

Achèvement de l'étude (Réel)

1 septembre 2011

Dates d'inscription aux études

Première soumission

15 octobre 2009

Première soumission répondant aux critères de contrôle qualité

15 octobre 2009

Première publication (Estimation)

16 octobre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

24 juin 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juin 2013

Dernière vérification

1 juin 2013

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

DR-103-301

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Prévention de la grossesse

Wafaa Uthman Ahmed
Ain Shams Maternity Hospital

Inconnue

Essai clinique randomisé pour la comparaison de la carbéitocine intraveineuse par rapport à l'ocytocine dans la gestion de l'accouchement placentaire lors d'une interruption du deuxième trimestre

CARBETOCINE POUR LA PREVENTION DE LA RETENUE PLACENTAIRE

Egypte
Bambino Gesù Hospital and Research Institute

Complété

Obalon chez les enfants souffrant d'obésité sévère (Obalon)

Obésité pédiatrique sévère (IMC > 97° pc -Selon les Centers for Disease Control and Prevention BMI Charts-) | Tests de la fonction hépatique altérée | Intolérance glycémique

Italie

Essais cliniques sur DR-103

Duramed Research

Complété

Évaluation du DR-2001 pour la prise en charge de la douleur pelvienne liée à l'endométriose

Endométriose

États-Unis
LivaNova

Complété

Évaluation du mode SafeR chez les patients avec indication de stimulateur double chambre (ANSWER)

Évaluer les avantages de l'algorithme AAISafeR/SafeR de Symphony 2550 ou REPLYTM DR chez un large éventail de patients porteurs d'un stimulateur cardiaque.

Italie, France, Espagne, États-Unis, Allemagne, Royaume-Uni
LivaNova

Complété

Thérapie anti-tachycardie optimale chez les patients porteurs d'un défibrillateur cardiaque implantable (DAI) sans indications de stimulation (OPTION)

Tachycardie

France, Allemagne, Le Portugal, Italie, Canada, États-Unis, Belgique, Pays-Bas, Royaume-Uni
InQpharm Group

Complété

Bénéfice et tolérance de l'IQP-AE-103 dans la perte de poids

Obésité | En surpoids

Allemagne
Hospices Civils de Lyon

Retiré

Surveillance de l'immunosuppression induite par les corticostéroïdes à l'aide de monocyte Human Leukocyte Antigen-DR (mHLA-DR). (HLA-DR)

Immunosuppression
Transwell Biotech Co., Ltd.

Complété

TWB-103 pour le traitement des ulcères des membres inférieurs chez les patients atteints de DM

Ulcère du pied diabétique

Taïwan
CellabMED

Recrutement

Une étude clinique sur le CAR-T ciblé par IL13Rα2 chez des patients atteints de gliome malin (MAGIC-I)

Gliome malin récurrent

Corée, République de
Takeda

Actif, ne recrute pas

Une étude du TAK-103 chez des adultes atteints de tumeurs solides

Tumeurs solides

Japon
Duramed Research

Complété

Un essai pour évaluer DR-2021 chez les femmes atteintes d'aménorrhée secondaire

Aménorrhée

États-Unis
Peptomyc S.L.

Résilié

Étude de phase 1/2 pour évaluer l'innocuité, la pharmacocinétique et l'efficacité de l'inhibiteur de MYC OMO-103 dans les tumeurs solides (MYCure)

Cancer du pancréas | Tumeurs solides avancées | CRC

Espagne

A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women

Aperçu de l'étude

Statut

Les conditions

Intervention / Traitement

Type d'étude

Inscription (Réel)

Phase

Contacts et emplacements

Lieux d'étude

Critères de participation

Critère d'éligibilité

Âges éligibles pour étudier

Accepte les volontaires sains

Sexes éligibles pour l'étude

La description

Plan d'étude

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de bras

Armes et Interventions

Groupe de participants / Bras

Intervention / Traitement

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats

Description de la mesure

Délai

Mesures de résultats secondaires

Mesure des résultats

Description de la mesure

Délai

Collaborateurs et enquêteurs

Parrainer

Publications et liens utiles

Publications générales

Dates d'enregistrement des études

Dates principales de l'étude

Début de l'étude

Achèvement primaire (Réel)

Achèvement de l'étude (Réel)

Dates d'inscription aux études

Première soumission

Première soumission répondant aux critères de contrôle qualité

Première publication (Estimation)

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

Dernière mise à jour soumise répondant aux critères de contrôle qualité

Dernière vérification

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

Essais cliniques sur Prévention de la grossesse

Essais cliniques sur DR-103

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Latvia

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements