Safety and effectiveness of different dosage of mifepristone for the treatment of uterine fibroids: a double-blind randomized clinical trial

Esteve, Josep Lluis Carbonell; Tomasi,

doi:10.2147/ijwh.s33125

Cited by 19 publications

(19 citation statements)

References 15 publications

(27 reference statements)

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“…Current studies support that growth of myoma is dependent on progesterone and therefore antiprogestins (mifepristone) and selective progesterone receptor modulators (SPRMs-Asoprisnil/Ulipristal) can be effective in treatment. Several clinical trials have been done since then with doses varying from 2.5 to 100 mg for 3-12 months [4]. Studies have found that a dose of 2.5 mg is not effective in reducing the myoma volume, but a dose as low as 5 mg per day and maximum as high as 50 mg per day was found effective [4,5].…”

Section: Discussionmentioning

confidence: 99%

“…Several clinical trials have been done since then with doses varying from 2.5 to 100 mg for 3-12 months [4]. Studies have found that a dose of 2.5 mg is not effective in reducing the myoma volume, but a dose as low as 5 mg per day and maximum as high as 50 mg per day was found effective [4,5]. In the present observational prospective ''before-after'' study, 50 mg mifepristone given once a week was used for 6 months.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy of Use of Long-Term, Low-Dose Mifepristone for the Treatment of Fibroids

Kapur

Angomchanu²,

Dey

2016

J Obstet Gynecol India

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Background Fibroid or myoma is the commonest reported tumor of uterus, and is one of the important reasons for hysterectomy in our setting. Different drugs are available for medical management of fibroid uterus including mifepristone, a progesterone antagonist. Varying dosage regimen for mifepristone was studied as medical management of fibroid uterus. The aim of the project was to study the effect of mifepristone on the symptoms and size of fibroids, especially using a low-dose regimen for 6 months. In addition, any symptomatic improvement of menorrhagia and dysmenorrhea was also studied. Methods The study was designed as an observational prospective ''before-after'' study. Women diagnosed with uterine fibroids attending OPD of a tertiary care hospital were selected according to the inclusion criteria. A total of 36 patients were enrolled in the study. Sample size was calculated to study changes in various parameters after 6 months treatment with mifepristone 50 mg once a week. Baseline investigations were performed and menstrual blood loss was assessed using pictorial blood assessment charts. Fifty milligrams of mifepristone weekly was used, and patient assessed at 1 and 6 month. They were also further followed up till 3 months after stopping the drug to 123 observe the changes in menstrual pattern, fibroid volume, hemoglobin and liver function tests. Baseline endometrial biopsy and another at 6 month on cessation of drug therapy were done for all patients.Results Majority of the study population comprised of perimenopausal women, i.e., 41-45 years (44 %). Fifty percent of the patients were Para 2 and belonged to the perimenopausal age-group (18 out of 36). The dominant presenting symptom was menorrhagia associated with dysmenorrhea and pelvic pain. After 6 months of treatment with mifepristone, the mean fibroid volume reduced from 204.33 to 113.16 cm 3 (n = 33); p B 0.001, and the percentage mean volume reduction of the fibroid in the study population was 44.57 % (range 1.10-100 %). Immediate reduction in bleeding PV was observed in 100 %, and 88.89 % (32/36) patients attained amenorrhea. The mean hemoglobin increased from 9.18 to 10.82 g/dl (p = 0.001).There was a transient rise in mean transaminases (AST/ ALT) levels at 6 months which reverted to normal at 9 months follow-up.Conclusion To conclude, 6 months therapy with 50 mg of mifepristone given weekly is efficacious and acceptable for the treatment of symptomatic leiomyoma, especially in a select group of patients. Although its use as a primary medical therapy is limited due to recurrence of fibroid after stopping treatment, it is useful for perimenopausal women whose myoma would regress after menopause, and younger infertile patients with small-size deep intramural myomas not easily accessible to either hysteroscopic or laparoscopic surgery. It is also beneficial as a preoperative adjunct, in patients with preoperative severe anemia and large fibroids where surgery is technically difficult. Mode of surgery can be changed to a lessinvasive vagina...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Efficacy of Use of Long-Term, Low-Dose Mifepristone for the Treatment of Fibroids

Kapur

Angomchanu²,

Dey

2016

J Obstet Gynecol India

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“…The oldest, almost pure antiprogestin, mifepristone, has shown great effectiveness with different dosages in multiple studies into the treatment of this condition [5, 6]. Mifepristone in 5 mg doses has proven itself to be an efficient and safe therapeutic medicine as well as achieving an observable improvement in quality of life [5–10]. Eisinger et al in a 17-case pilot study using 2.5 mg doses of mifepristone obtain lesser reductions in uterine volume, but a similar quality of life in comparison with 5 mg mifepristone [11].…”

Section: Introductionmentioning

confidence: 99%

Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial

Carbonell¹,

Acosta

Pérez

et al. 2013

ISRN Obstetrics and Gynecology

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Objectives. To evaluate the efficacy, safety, and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9-month followup period. Design. Randomized clinical trial. Place. “Eusebio Hernández” Hospital, Havana, Cuba. Subjects. 220 women with symptomatic uterine fibroids. Treatment. One-half (2.5 mg) or one-whole 5 mg mifepristone tablet. Variables to Evaluate Efficacy. Changes in fibroid and uterine volumes, in symptomatic prevalence and intensity, and in quality of life. Results. After 3-month treatment, fibroid volume decreased by 27.9% (CI 95% 20–35) and 45.5% (CI 95% 37–62), in the 2.5 and 5 mg groups, respectively, P = 0.003. There was no difference in the prevalence of symptoms at the end of treatment, unlike after 6- and 9-month followup when there was a difference. Amenorrhea was significantly higher in the 5 mg group, P = 0.001. There were no significant differences in mifepristone side effects between the groups. Both groups displayed a similar improvement in quality of life. Conclusions. The 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose. This trial is registered with ClinicalTrials.gov NCT01786226.

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“…However, in follow-up biopsies taken 6 months after the end of the treatment, these changes were shown to be reversible and comparable to control groups and to baseline occurrence. For mifepristone, after 9 months exposure a comparable frequency of PAEC could be observed [69].…”

Section: Tolerability Profile Of Sprmsmentioning

confidence: 74%

“…For mifepristone, after 3 months of therapy, a thickening of the endometrium of >8 mm was observed for 21.2 and 48.6% of subjects in the 5 and 10 mg group, respectively. The frequency of occurrence did not increase with prolonged treatment exposure up to 9 months (TABLE 1) [69].…”

Section: Tolerability Profile Of Sprmsmentioning

confidence: 91%

The potential of selective progesterone receptor modulators for the treatment of uterine fibroids

Bestel

Donnez

2013

Expert Review of Endocrinology & Metabolism

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In addition to the estrogen receptor, the progesterone receptor plays an important role in the growth of uterine fibroids. Several selective progesterone receptor modulators (SPRMs) have been evaluated for medical treatment of uterine fibroids and, because of safety issues, some molecules were stopped during clinical development. However, in 2012, ulipristal acetate received the approval for a pre-surgical treatment of uterine fibroids. Clinical trials with ulipristal acetate for long-term medical treatment of uterine fibroids are ongoing. This review article describes the action of SPRMs at the progesterone receptor level and the mechanism of action on the fibroid tissue. A review of the published clinical trials is performed, including the current evidence of efficacy on uterine fibroid symptom management, size reduction and tolerability. The therapeutic potential of SPRMs for uterine fibroids is discussed. KEYWORDS: asoprisnil • estrogen receptor • GnRH-agonist • mifepristone • progesterone receptor • progesterone receptor modulators • SPRM • telapristone acetate • ulipristal acetate • uterine fibroidsUterine fibroids are the most frequent tumor of the female genital tract with an increasing frequency during the women's fertile years with a prevalence of 20-77% depending on the population and method of assessment [1][2][3]. Its incidence increases with increasing age and the life time risk for women to develop uterine fibroids is 70% [4]. Uterine fibroids are more frequent and appear at an earlier age in black women, whereas the incidence of fibroids in Asian or Hispanic women is comparable to the incidence in Caucasian women [1,2,4].

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Safety and effectiveness of different dosage of mifepristone for the treatment of uterine fibroids: a double-blind randomized clinical trial

Cited by 19 publications

References 15 publications

Efficacy of Use of Long-Term, Low-Dose Mifepristone for the Treatment of Fibroids

Efficacy of Use of Long-Term, Low-Dose Mifepristone for the Treatment of Fibroids

Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial

The potential of selective progesterone receptor modulators for the treatment of uterine fibroids

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