A Randomized, Controlled Trial of Asoprisnil, a Novel Selective Progesterone Receptor Modulator, in Women With Uterine Leiomyomata
Notice bibliographique
Résumé
The only effective medical treatment of symptomatic uterine leiomyomas has been the gonadotropin-releasing hormone agonist leuprolide acetate depot, which carries a risk of producing hypoestrogenic symptoms. High-dose progestin therapy has been used to control heavy uterine bleeding (HUB) but may cause breakthrough bleeding. Another option is asoprisnil, a selective progesterone (P) receptor modulator that has mixed P agonist and antagonist actions and is highly uterine-selective. In both primate and human studies, it has induced amenorrhea and suppressed endometrial growth. This randomized prospective, double-blind, placebo-control study, carried out at 28 sites in the United States and 1 in Canada, enrolled 129 women 18 to 49 years of age who had at least one leiomyoma measuring 3 cm or more in diameter or multiple small lesions producing a uterine volume exceeding 200 cm3. All participants had normal menses and no other significant pelvic pathology. They received either asoprisnil in a daily oral dose of 5, 10, or 25 mg or a placebo for 12 weeks. Uterine bleeding was monitored by daily diaries, and uterine volume was measured sonographically. The 5-, 10-, and 25-mg doses of asoprisnil suppressed uterine bleeding in 28%, 64%, and 83% of patients, respectively. These patients did not have even light bleeding while being treated. No placebo recipient responded. Dose-related rates of amenorrhea, defined as no bleeding or only spotting, were 16%, 36%, and 70%, respectively. Compared with placebo, treatment with 25 mg daily for 4 and 8 weeks was associated with a statistically significant decrease in leiomyoma volume, and by week 12 it was reduced by 36%. The higher doses of asoprisnil significantly reduced bloating and, in patients given 25 mg daily, pelvic pressure also declined significantly by week 12. Hemoglobin concentrations increased significantly more in all treatment groups than in placebo recipients. Treatment had no apparent effect on pelvic pain or dyspareunia. Hypoestrogenic symptoms were minimal. Endometrial thickness was similar in the treatment and placebo groups at the end of the study, and no hyperplasia or other adverse changes were observed. Asoprisnil therapy appeared to inhibit basal gonadotropin concentrations. There were no clinically significant changes in blood chemistry or blood pressure, and no clinically relevant cervical abnormalities were observed. Adverse effects of all types were similarly frequent in the treatment and placebo groups. These findings support the use of asoprisnil to treat complaints related to uterine leiomyomas, notably HUB and bulk-related symptoms, without significantly altering blood estrogen levels at the same time. Treatment with doses as high as 25 mg daily for 12 weeks was well tolerated.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».