scholarly journals Neurokinin B Receptor Antagonism in Women With Polycystic Ovary Syndrome: A Randomized, Placebo-Controlled Trial

2016 ◽  
Vol 101 (11) ◽  
pp. 4313-4321 ◽  
Author(s):  
Jyothis T. George ◽  
Rahul Kakkar ◽  
Jayne Marshall ◽  
Martin L. Scott ◽  
Richard D. Finkelman ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Receptor Antagonist ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Pulse Frequency ◽  
Ovary Syndrome ◽  
Receptor Antagonism ◽  
Serum Lh ◽  
Nk3 Receptor

Context: Polycystic ovary syndrome (PCOS), the most common endocrinopathy in women, is characterized by high secretion levels of LH and T. Currently, there is no treatment licensed specifically for PCOS. Objective: The objective of this study was to investigate whether a targeted therapy would decrease LH pulse frequency in women with PCOS, subsequently reducing serum LH and T concentrations and thereby presenting a novel therapeutic approach to the management of PCOS. Design: This study is a double-blind, double-dummy, placebo-controlled, phase 2 trial. Settings: University hospitals and private clinical research centers were included. Participants: Women with PCOS aged 18–45 years participated. Intervention: Intervention included AZD4901 (a specific neurokinin-3 [NK3] receptor antagonist) at a dose of 20, 40, or 80 mg/day or matching placebo for 28 days. Main Outcome Measure: Change from baseline in the area under the LH serum concentration–time curve over 8 hours (area under the curve) on day 7 relative to placebo was measured. Results: Of a total 67 randomized patients, 65 were evaluable. On day 7, the following baseline-adjusted changes relative to placebo were observed in patients receiving AZD4901 80 mg/day: 1) a reduction of 52.0% (95% confidence interval [CI], 29.6–67.3%) in LH area under the curve; 2) a reduction of 28.7% (95% CI, 13.9–40.9%) in total T concentration; and 3) a reduction of 3.55 LH pulses/8 hours (95% CI, 2.0–5.1) (all nominal P < .05). Conclusions: The NK3 receptor antagonist AZD4901 specifically reduced LH pulse frequency and subsequently serum LH and T concentrations, thus presenting NK3 receptor antagonism as a potential approach to treating the central neuroendocrine pathophysiology of PCOS.

scholarly journals Randomized Controlled Trial of Neurokinin 3 Receptor Antagonist Fezolinetant for Treatment of Polycystic Ovary Syndrome

2021 ◽  
Author(s):  
Graeme L Fraser ◽  
Barbara Obermayer-Pietsch ◽  
Joop Laven ◽  
Georg Griesinger ◽  
Axelle Pintiaux ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Receptor Antagonist ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Total Testosterone ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Nk3 Receptor ◽  
Neurokinin 3 Receptor ◽  
Dose Dependent Decrease

Abstract Context Polycystic ovary syndrome (PCOS), a highly prevalent endocrine disorder characterized by hyperandrogenism, is the leading cause of anovulatory infertility. Objective This proof-of-concept study evaluated clinical efficacy and safety of the neurokinin 3 (NK3) receptor antagonist fezolinetant in PCOS. Design This was a phase 2a, randomized, double-blind, placebo-controlled, multicenter study (EudraCT 2014-004409-34). Setting The study was conducted at 5 European clinical centers. Patients Women with PCOS participated in the study. Intervention Interventions included fezolinetant 60 or 180 mg/d or placebo for 12 weeks. Main Outcome Measure The primary efficacy endpoint was change in total testosterone. Gonadotropins, ovarian hormones, and safety/tolerability were also assessed. Results Seventy-three women were randomized, and 64 participants completed the study. Adjusted mean (SE) changes in total testosterone from baseline to week 12 for fezolinetant 180 and 60 mg/d were −0.80 (0.13) and −0.39 (0.12) nmol/L versus −0.05 (0.10) nmol/L with placebo (P<0.0001 and P<0.05, respectively). Adjusted mean (SE) changes from baseline in luteinizing hormone (LH) for fezolinetant 180 and 60 mg/d were −10.17 (1.28) and −8.21 (1.18) versus −3.16 (1.04) IU/L with placebo (P<0.0001 and P=0.0022); corresponding changes in follicle-stimulating hormone (FSH) were −1.46 (0.32) and −0.92 (0.30) versus −0.57 (0.26) IU/L (P=0.0336 and P=0.3770), underpinning a dose-dependent decrease in the LH-to-FSH ratio versus placebo (P<0.001). Circulating levels of progesterone and estradiol did not change significantly versus placebo (P>0.1). Fezolinetant was well tolerated. Conclusions Fezolinetant had a sustained effect to suppress hyperandrogenism and reduce the LH-to-FSH ra

scholarly journals Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome: Study Design of a Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Hongying Kuang ◽  
Yan Li ◽  
Xiaoke Wu ◽  
Lihui Hou ◽  
Taixiang Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Polycystic Ovary Syndrome ◽  
Live Birth ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Clomiphene Citrate ◽  
Fertility Treatment ◽  
Ovary Syndrome ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Acupuncture is an alternative therapy to induce ovulation in women with polycystic ovary syndrome (PCOS), but there is no study reporting the live birth rate following ovulation induction by acupuncture or its potential as an adjuvant treatment to clomiphene citrate (CC). We assess the efficacy of acupuncture with or without CC in achieving live births among 1000 PCOS women in Mainland China. This paper reports the methodology of an ongoing multicenter randomized controlled trial. The randomization scheme is coordinated through the central mechanism and stratified by the participating sites. Participants will be randomized into one of the four treatment arms: (A) true acupuncture and CC, (B) control acupuncture and CC, (C) true acupuncture and placebo CC, and (D) control acupuncture and placebo CC. To ensure the quality and integrity of the trial we have developed a unique multinational team of investigators and Data and Safety Monitoring Board. Up to the end of April 2013, 326 subjects were recruited. In conclusion, the success of this trial will allow us to evaluate the additional benefit of acupuncture beyond the first line medicine for fertility treatment in PCOS women in an unbiased manner.

Effect of sibutramine on weight reduction in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial

2008 ◽  
Vol 89 (5) ◽  
pp. 1221-1228 ◽  
Author(s):  
Åsa Lindholm ◽  
Marie Bixo ◽  
Inger Björn ◽  
Pål Wölner-Hanssen ◽  
Mats Eliasson ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Weight Reduction ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Haiqing Qian ◽  
Wenting Xu ◽  
Lijuan Cui ◽  
Rong Wang ◽  
Jiahui Wang ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Menstrual Cycle ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Close Monitoring ◽  
Ovary Syndrome ◽  
Kidney Deficiency ◽  
Randomized Controlled

Abstract Background Polycystic ovary syndrome (PCOS) is a common reproductive endocrine disease in women. Insulin resistance (IR) has emerged as a central contributor to the pathogenesis of this disease. According to traditional Chinese medicine (TCM), kidney deficiency is the main syndrome of PCOS. The deficiency of the kidney cannot vaporize water-dampness, and the retention of water-dampness accumulates into phlegm dampness stagnation, resulting in visceral dysfunction and metabolic disorder. TCM involving syndrome differentiation and treatment is widely used to adjust women’s menstrual cycles. Our patented formula Bushen Huatan Decoction (BSHTD) has been proven to be effective in the clinical treatment of IR-PCOS. Baduanjin also plays an important role in improving metabolic syndrome through lifestyle intervention. This study investigates the clinical efficacy of Bushen Huatan Decoction combined with Baduanjin in IR-PCOS, to form a specific TCM-behaviour intervention plan in the treatment of IR-PCOS. Methods/design This is a randomized controlled trial involving 190 participants diagnosed with IR-PCOS. All participants will be randomly allocated into 5 groups: group A will receive metformin; group B, BSHTD; group C, Baduanjin; group D, BSHTD combined with metformin; and group E, BSHTD combined with Baduanjin. One course of treatment lasts 3 months, a total of two courses. The primary outcomes are changes in the homeostatic model assessment of insulin resistance (HOMA-IR) and improvements in the oral glucose tolerance test (OGTT) and insulin-releasing test (INS). The secondary outcomes are improvements in the menstrual cycle, ovulation rate, clinical pregnancy rate, basic serum sex hormone levels, free androgen index (FAI), Ferriman-Gallwey scores, body mass index (BMI) and TCM syndrome scores. The related observation indexes will be collected at baseline, during the process of treatment and at the 6-month follow-up. Simultaneously, close monitoring of possible adverse events will be performed throughout the trial process. Discussion This trial will investigate the efficacy of the comprehensive intervention program of Bushen Huatan Decoction combined with Baduanjin on the adjustment of the menstrual cycle, improvement of insulin resistance and correction of glucose metabolism disorder in IR-PCOS patients. It is expected to form an alternative treatment of TCM-behaviour intervention therapy for IR-PCOS and promote the Chinese fitness Qigong Baduanjin in the application of lifestyle diseases. Trial registration Chinese Clinical Trial Registry ChiCTR2100043415. Registered on 15 February 2021.

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