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Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding - ovulation dysfunction patients.

ABSTRACT: BACKGROUND:Dydrogesterone has shown significant efficacy in treatment of irregular menstrual cycle due to abnormal uterine bleeding - ovulation dysfunction (AUB-O), but there were few relevant studies. This observational study was designed to evaluate the effectiveness of dydrogesterone for the treatment of Chinese patients with AUB-O. AIM:To evaluate the effects of dydrogesterone on menstrual-cycle (MC) regularization and metabolism in the patients with AUB-O. METHODS:A prospective, non-interventional, single-arm, post-marketing observational study was conducted. Chinese women aged 16 years or above with AUB-O who had been prescribed dydrogesterone were enrolled. The patients were treated with dydrogesterone 10 mg from day 16 to day 25 of each cycle, consecutively for at least 3 cycles. The main outcome was defined as the percentage of patients whose MCs returned to normal (defined as 21 d < menstrual cycle ? 35 d) after three cycles of dydrogesterone treatment. RESULTS:One hundred and fourteen women with AUB-O were enrolled in the present study. Of 89 patients who completed treatment, 72 (80.9%) achieved a regular MC at the end of the 3rd circle. The level of androgen, including testosterone and dehydroepiandrosterone sulfate, declined significantly (P = 0.01 and 0.031, respectively), whereas other hormone levels remained steady. During the treatment, 44/80 (55.0%) subjects in the per-protocol set had reported biphasic basal body temperature. CONCLUSION:Dydrogesterone therapy was effective in achieving MC regularization for Chinese patients with AUB-O.

SUBMITTER: Wang L

PROVIDER: S-EPMC7441273 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding - ovulation dysfunction patients.

Wang Lu L Guan Hai-Yun HY Xia He-Xia HX Chen Xiu-Ying XY Zhang Wei W

World journal of clinical cases 20200801 15

<h4>Background</h4>Dydrogesterone has shown significant efficacy in treatment of irregular menstrual cycle due to abnormal uterine bleeding - ovulation dysfunction (AUB-O), but there were few relevant studies. This observational study was designed to evaluate the effectiveness of dydrogesterone for the treatment of Chinese patients with AUB-O.<h4>Aim</h4>To evaluate the effects of dydrogesterone on menstrual-cycle (MC) regularization and metabolism in the patients with AUB-O.<h4>Methods</h4>A pr ...[more]

PMID: 32874980

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Project description:BackgroundUse of menstrual tracking data to understand abnormal bleeding patterns has been limited because of lack of incorporation of key demographic and health characteristics and confirmation of menstrual tracking accuracy.ObjectiveThis study aimed to identify abnormal uterine bleeding patterns and their prevalence and confirm existing and expected associations between abnormal uterine bleeding patterns, demographics, and medical conditions.Study designApple Women's Health Study participants from November 2019 through July 2021 who contributed menstrual tracking data and did not report pregnancy, lactation, use of hormones, or menopause were included in the analysis. Four abnormal uterine bleeding patterns were evaluated: irregular menses, infrequent menses, prolonged menses, and irregular intermenstrual bleeding (spotting). Monthly tracking confirmation using survey responses was used to exclude inaccurate or incomplete digital records. We investigated the prevalence of abnormal uterine bleeding stratified by demographic characteristics and used logistic regression to evaluate the relationship of abnormal uterine bleeding to a number of self-reported medical conditions.ResultsThere were 18,875 participants who met inclusion criteria, with a mean age of 33 (standard deviation, 8.2) years, mean body mass index of 29.3 (standard deviation, 8.0), and with 68.9% (95% confidence interval, 68.2-69.5) identifying as White, non-Hispanic. Abnormal uterine bleeding was found in 16.4% of participants (n=3103; 95% confidence interval, 15.9-17.0) after accurate tracking was confirmed; 2.9% had irregular menses (95% confidence interval, 2.7-3.1), 8.4% had infrequent menses (95% confidence interval, 8.0-8.8), 2.3% had prolonged menses (95% confidence interval, 2.1-2.5), and 6.1% had spotting (95% confidence interval, 5.7-6.4). Black participants had 33% higher prevalence (prevalence ratio, 1.33; 95% confidence interval, 1.09-1.61) of infrequent menses compared with White, non-Hispanic participants after controlling for age and body mass index. The prevalence of infrequent menses was increased in class 1, 2, and 3 obesity (class 1: body mass index, 30-34.9; prevalence ratio, 1.31; 95% confidence interval, 1.13-1.52; class 2: body mass index, 35-39.9; prevalence ratio, 1.25; 95% confidence interval, 1.05-1.49; class 3: body mass index, >40; prevalence ratio, 1.51; 95% confidence interval, 1.21-1.88) after controlling for age and race/ethnicity. Those with class 3 obesity had 18% higher prevalence of abnormal uterine bleeding compared with healthy-weight participants (prevalence ratio, 1.18; 95% confidence interval, 1.02-1.38). Participants with polycystic ovary syndrome had 19% higher prevalence of abnormal uterine bleeding compared with participants without this condition (prevalence ratio, 1.19; 95% confidence interval, 1.08-1.31). Participants with hyperthyroidism (prevalence ratio, 1.34; 95% confidence interval, 1.13-1.59) and hypothyroidism (prevalence ratio, 1.17; 95% confidence interval, 1.05-1.31) had a higher prevalence of abnormal uterine bleeding, as did those reporting endometriosis (prevalence ratio, 1.28; 95% confidence interval, 1.12-1.45), cervical dysplasia (prevalence ratio, 1.20; 95% confidence interval, 1.03-1.39), and fibroids (prevalence ratio, 1.14; 95% confidence interval, 1.00-1.30).ConclusionIn this cohort, abnormal uterine bleeding was present in 16.4% of those with confirmed menstrual tracking. Black or obese participants had increased prevalence of abnormal uterine bleeding. Participants reporting conditions such as polycystic ovary syndrome, thyroid disease, endometriosis, and cervical dysplasia had a higher prevalence of abnormal uterine bleeding.

Project description:ObjectiveTo compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy.DesignPragmatic multicentre randomised controlled non-inferiority study.SettingOutpatient hysteroscopy clinics in 31 UK National Health Service hospitals.Participants507 women who attended as outpatients for diagnostic hysteroscopy because of abnormal uterine bleeding and were found to have uterine polyps.InterventionsParticipants were randomly assigned to either outpatient uterine polypectomy under local anaesthetic or inpatient uterine polypectomy under general anaesthesia. Data were collected on women's self reported bleeding symptoms at baseline and at 6, 12, and 24 months. Data were also collected on pain and acceptability of the procedure at the time of polypectomy.Main outcome measuresThe primary outcome was successful treatment, determined by the women's assessment of bleeding at six months, with a prespecified non-inferiority margin of 25%. Secondary outcomes included generic (EQ-5D) and disease specific (menorrhagia multi-attribute scale) quality of life, and feasibility and acceptability of the procedure.Results73% (166/228) of women in the outpatient group and 80% (168/211) in the inpatient group reported successful treatment at six months (intention to treat relative risk 0.91, 95% confidence interval 0.82 to 1.02; per protocol relative risk 0.92, 0.82 to 1.02). Failure to remove polyps was higher (19% v 7%; relative risk 2.5, 1.5 to 4.1) and acceptability of the procedure was lower (83% v 92%; 0.90, 0.84 to 0.97) in the outpatient group Quality of life did not differ significantly between the groups. Four uterine perforations, one of which necessitated bowel resection, all occurred in the inpatient group.ConclusionsOutpatient polypectomy was non-inferior to inpatient polypectomy. Failure to remove a uterine polyp was, however, more likely with outpatient polypectomy and acceptability of the procedure was slightly lower.Trial registrationInternational Clinical Trials Registry 65868569.

Project description:ObjectiveTo investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas.MethodsElaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of women with both less than 80 mL menstrual blood loss during final month and a 50% or greater reduction in menstrual blood loss from baseline to final month. Safety evaluations included adverse events and bone mineral density changes. The planned sample size of UF-EXTEND was based on estimated rollover and discontinuation rates in the two preceding studies.ResultsFrom September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean±SD age of this group was 42.4±5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}.ConclusionUp to 12 months of elagolix with add-back therapy provided sustained reduction in menstrual blood loss in women with uterine leiomyomas, with the addition of add-back therapy attenuating the hypoestrogenic effects of elagolix alone. No new or unexpected safety concerns were associated with an additional 6 months of elagolix with addback therapy.Clinical trial registrationClinicalTrials.gov, NCT02925494.Funding sourceAbbVie Inc funded this study.

Dataset Information

Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding - ovulation dysfunction patients.

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Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding - ovulation dysfunction patients.

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