scholarly journals The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata

2007 ◽  
Vol 22 (6) ◽  
pp. 1696-1704 ◽  
Author(s):  
A.R.W. Williams ◽  
H.O.D. Critchley ◽  
J. Osei ◽  
S. Ingamells ◽  
I.T. Cameron ◽  
...  
Keyword(s):  
Progesterone Receptor ◽  
Uterine Leiomyomata ◽  
Receptor Modulator

A Randomized, Controlled Trial of Asoprisnil, a Novel Selective Progesterone Receptor Modulator, in Women With Uterine Leiomyomata

2007 ◽  
Vol 62 (10) ◽  
pp. 662-663
Author(s):  
Kristof Chwalisz ◽  
Lois Larsen ◽  
Cynthia Mattia-Goldberg ◽  
Anthony Edmonds ◽  
Walter Elger ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Progesterone Receptor ◽  
Controlled Trial ◽  
Uterine Leiomyomata ◽  
Randomized Controlled ◽  
Receptor Modulator

A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata

2007 ◽  
Vol 87 (6) ◽  
pp. 1399-1412 ◽  
Author(s):  
Kristof Chwalisz ◽  
Lois Larsen ◽  
Cynthia Mattia-Goldberg ◽  
Anthony Edmonds ◽  
Walter Elger ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Progesterone Receptor ◽  
Controlled Trial ◽  
Uterine Leiomyomata ◽  
Randomized Controlled ◽  
Receptor Modulator

scholarly journals Effects of the Selective Progesterone Receptor Modulator Asoprisnil on Uterine Artery Blood Flow, Ovarian Activity, and Clinical Symptoms in Patients with Uterine Leiomyomata Scheduled for Hysterectomy

2008 ◽  
Vol 93 (12) ◽  
pp. 4664-4671 ◽  
Author(s):  
Julia Wilkens ◽  
Kristof Chwalisz ◽  
Cong Han ◽  
Jane Walker ◽  
Iain T. Cameron ◽  
...  
Keyword(s):  
Blood Flow ◽  
Progesterone Receptor ◽  
Pulsatility Index ◽  
Uterine Artery ◽  
Resistance Index ◽  
Controlled Study ◽  
Clinical Effects ◽  
Artery Blood Flow ◽  
Uterine Leiomyomata ◽  
Receptor Modulator

Introduction: Asoprisnil, a novel orally active selective progesterone receptor modulator, is being studied for the management of symptomatic uterine leiomyomata. The exact mechanism of action is not yet discerned. The primary objectives of this double-blind, randomized, placebo-controlled study included evaluation of the effect of asoprisnil on uterine artery blood flow. Furthermore, we assessed effects of asoprisnil on leiomyoma symptoms. Patients and Methods: Thirty-three premenopausal patients scheduled for hysterectomy due to symptomatic uterine leiomyomata were recruited in four centers and treated with 10 or 25 mg asoprisnil or placebo for 12 wk before surgery. At baseline and before hysterectomy, all patients underwent sonographic assessment to measure impedance to uterine artery blood flow, determined by resistance index and pulsatility index, as well as volumes of largest leiomyoma and uterus. In addition, patients recorded intensity and frequency of menstrual bleeding on a menstrual pictogram. Each asoprisnil treatment was compared with placebo. Results: The increased pulsatility index in both asoprisnil groups and the statistically significantly increased resistance index within the 25-mg asoprisnil group suggest a moderately decreased uterine artery blood flow. Analysis of menstrual pictogram scores showed a statistically significant larger decrease in frequency and intensity of bleeding for both asoprisnil groups compared with placebo. Bleeding was suppressed by asoprisnil 25mg in 91% of patients. Asoprisnil treatment was well tolerated when administered daily for a 12-wk period, and no serious adverse events occurred. Conclusion: Asoprisnil moderately reduced uterine artery blood flow. This effect may contribute in part to the clinical effects of asoprisnil.

scholarly journals Brain reactivity during aggressive response in women with premenstrual dysphoric disorder treated with a selective progesterone receptor modulator

2021 ◽  
Author(s):  
Elisavet Kaltsouni ◽  
Patrick M. Fisher ◽  
Manon Dubol ◽  
Steinar Hustad ◽  
Rupert Lanzenberger ◽  
...  
Keyword(s):  
Progesterone Receptor ◽  
Negative Relationship ◽  
Premenstrual Dysphoric Disorder ◽  
Aggressive Response ◽  
Anterior Cingulate ◽  
Reproductive Age ◽  
Gonadal Hormone ◽  
Dorsal Anterior Cingulate Cortex ◽  
Response Condition ◽  
Receptor Modulator

AbstractPremenstrual dysphoric disorder (PMDD) is a psychiatric condition characterized by late luteal phase affective, cognitive, and physical impairment. The disorder causes significant suffering in about 5% of women in their reproductive age. Altered sensitivity of cognitive-affective brain circuits to progesterone and its downstream metabolite allopregnanolone is suggested to underlie PMDD symptomatology. Core mood symptoms include irritability and anger, with aggression being the behavioral outcome of these symptoms. The present study sought to investigate the neural correlates of reactive aggression during the premenstrual phase in women with PMDD, randomized to a selective progesterone receptor modulator (SPRM) or placebo. Self-reports on the Daily Record of Severity of Problems were used to assess PMDD symptoms and gonadal hormone levels were measured by liquid chromatography tandem mass spectrometry. Functional magnetic resonance imaging was performed in 30 women with PMDD, while performing the point subtraction aggression paradigm. Overall, a high SPRM treatment response rate was attained (93%), in comparison with placebo (53.3%). Women with PMDD randomized to SPRM treatment had enhanced brain reactivity in the dorsal anterior cingulate cortex and dorsomedial prefrontal cortex during the aggressive response condition. The fronto-cingulate reactivity during aggressive responses depended on treatment, with a negative relationship between brain reactivity and task-related aggressiveness found in the placebo but not the SPRM group. The findings contribute to define the role of progesterone in PMDD symptomatology, suggesting a beneficial effect of progesterone receptor antagonism, and consequent anovulation, on top-down emotion regulation, i.e., greater fronto-cingulate activity in response to provocation stimuli.

scholarly journals Effects of the Progesterone Receptor Modulator VA2914 in a Continuous Low Dose on the Hypothalamic-Pituitary-Ovarian Axis and Endometrium in Normal Women: A Prospective, Randomized, Placebo-Controlled Trial

2007 ◽  
Vol 92 (9) ◽  
pp. 3582-3589 ◽  
Author(s):  
Nathalie Chabbert-Buffet ◽  
Axelle Pintiaux-Kairis ◽  
Philippe Bouchard
Keyword(s):  
Progesterone Receptor ◽  
Endometrial Hyperplasia ◽  
Low Dose ◽  
Ethinyl Estradiol ◽  
Controlled Trial ◽  
Endometrial Biopsy ◽  
Receptor Modulator ◽  
Phase Range ◽  
Normal Women ◽  
Estradiol Levels

Abstract Context: Progestin-only pills, the main hormonal alternative to ethinyl estradiol-containing pills in women bearing vascular risk factors, are poorly tolerated due to irregular bleeding. In contrast, progesterone receptor modulators can inhibit ovulation, alter endometrial receptivity, and improve cycle control. Objective: We evaluated the effects of a new progesterone receptor modulator, VA2914, administered continuously for 3 months, on ovulation and endometrial maturation. Design, Settings, and Patients: Forty-six normal women were included in a prospective, placebo-controlled, randomized trial, conducted in four referral centers. Intervention: VA2914 (2.5, 5, or 10 mg/d) was administered continuously for 84 d. Pelvic ultrasound (treatment d 67 and 77), hormonal monitoring (FSH, LH, estradiol, and progesterone on treatment d 59, 63, 67, 70, 74, 77, 80, and 84), and endometrial biopsy (treatment d 77) were performed. Main Outcome Measure: Ovulation inhibition was assessed by the absence of progesterone values above 3 ng/ml at any time during treatment month 3. Results: Anovulation was observed in 81.8% women in the 5-mg group and 80% in the 10-mg group, and amenorrhea occurred in 81.2 and 90% of cases in the 5- and 10-mg groups. We did not detect any cases of endometrial hyperplasia despite estradiol levels that remained in the physiological follicular phase range throughout treatment cycle 3. Conclusions: Continuous low-dose VA2914 can induce amenorrhea and inhibit ovulation without down-regulating estradiol levels or inducing endometrial hyperplasia in normal women. Long-term studies with a larger population are required to confirm the contraceptive efficacy of this regimen.

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