- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00680394
Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Non-surgical abortion methods have the potential to improve the quality and safety of women's reproductive health in the developing world. However, until recently, widespread availability and utilization of medical abortion with mifepristone in low resource countries has been restricted by the limited availability of mifepristone and perceived high cost of the drug, while the low and varied rates of efficacy of the misoprostol alone regimens have hindered its widespread adoption. In recent years, a handful of new mifepristone and misoprostol products have come to the market, easing the availability and reducing the cost of both drugs, and therefore making their introduction in new settings more feasible. Nonetheless, mifepristone is much more expensive than misoprostol (approximately $4 - 6 a tablet versus $0.35 a tablet) and often a large part of the cost of the medical abortion cost. In this respect, this study provides an important opportunity to better understand the real difference in efficacy of the two regimens in addition to the costs and benefits of these two non-surgical abortion regimens.
The study will contribute greatly to the literature on medical abortion. First, it will be the first randomized trial to compare two buccal regimens (and the second ever to compare mifepristone+misoprostol with misoprostol alone. Second, if proven efficacious, it promises to offer alternative regimens for use in women with gestations up to 63 days' LMP. Third, it may create evidence in support of shortening the time to abortion completion, by offering all women in the mifepristone arm the chance to complete their abortions 24 hours after mifepristone, instead of the standard 48 hours later. Lastly, it provides a unique opportunity to systematically and in a non-biased manner, compare the side effects and acceptability of these two regimens, thereby creating more information to help providers and policy makers debate the relative costs and benefits of these two medical abortion regimens.
A total of 700 women will be recruited. We assume that the efficacy of mifepristone plus buccal misoprostol is approximately 95%. The efficacy of misoprostol alone for medical abortion, via the vaginal route, is 88%. The efficacy of misoprostol alone via the buccal route is not known, nor is the efficacy via the buccal route with repeat dosing after a 24 hour interval. We expect that the efficacy with buccal misoprostol should be similar to that with vaginal misoprostol based on both pharmokinetic and clinical data.
We assume that the efficacy of mifepristone plus buccal misoprostol in our research settings will be 95%. A difference in efficacy of buccal misoprostol alone of at least 5% (90%) is clinically meaningful to providers and women.
Using alpha = 0.05 with a one-sided test and power = 0.80, the number needed to demonstrate this difference is 664 (334 in each arm). Assuming 5% will drop out or not complete the protocol, we plan to enroll a total of 700 women.
The primary endpoint is efficacy; safety, acceptability and side effects will be assessed as secondary endpoints.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Gestational age < 63 days by LMP, ultrasound or clinical assessment.
- General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
- Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- Able to consent to study participation.
Exclusion Criteria:
- Gestational age > 63 days
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion including IUD in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: mifepristone+misoprostol
200 mg mifepristone+ 800 mcg buccal misoprostol
|
200 mg mifepristone
800 buccal misoprostol + matching placebo or 1600 buccal misoprostol
|
Expérimental: misoprostol
800 mcg buccal misoprostol+placebo
|
800 buccal misoprostol + matching placebo or 1600 buccal misoprostol
800 buccal misoprostol + matching placebo or 1600 buccal misoprostol
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Efficacy defined as complete abortion without recourse to surgical abortion.
Délai: 2 weeks
|
2 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Blum J, Raghavan S, Dabash R, Ngoc Nt, Chelli H, Hajri S, Conkling K, Winikoff B. Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam. Int J Gynaecol Obstet. 2012 Aug;118(2):166-71. doi: 10.1016/j.ijgo.2012.03.039. Epub 2012 Jun 8.
- Ngoc NT, Blum J, Raghavan S, Nga NT, Dabash R, Diop A, Winikoff B. Comparing two early medical abortion regimens: mifepristone+misoprostol vs. misoprostol alone. Contraception. 2011 May;83(5):410-7. doi: 10.1016/j.contraception.2010.09.002. Epub 2010 Oct 18.
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
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Agents gastro-intestinaux
- Hormones, substituts hormonaux et antagonistes hormonaux
- Antagonistes hormonaux
- Agents contraceptifs, hormonaux
- Agents contraceptifs
- Agents de contrôle de la reproduction
- Contraceptifs oraux
- Agents contraceptifs, femmes
- Agents anti-ulcéreux
- Contraceptifs, Oraux, Synthétiques
- Agents abortifs, non stéroïdiens
- Agents abortifs
- Ocytociques
- Agents lutéolytiques
- Agents abortifs, stéroïdiens
- Contraceptifs, post-coïtaux, synthétiques
- Contraceptifs post-coïtaux
- Agents induisant les menstruations
- Misoprostol
- Mifépristone
Autres numéros d'identification d'étude
- Protocol 1.2.1
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