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In two international, randomized, double-blind, 24-week, phase 3 trials involving women with uterine fibroid–associated heavy menstrual bleeding, therapy with relugolix (an oral gonadotropin-releasing hormone receptor antagonist), combined with estradiol and norethindrone acetate, led to a significant reduction in menstrual bleeding while preserving bone mineral density.

In two identical, double-blind, randomized, 6-month phase 3 trials, elagolix (an oral gonadotropin-releasing hormone antagonist), administered with hormonal add-back therapy (estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) was more effective in reducing heavy menstrual bleeding in women with uterine fibroids than placebo. Bone loss was attenuated with add-back therapy, as compared with elagolix alone.

In this trial involving women with symptomatic fibroids who were planning to undergo surgery, treatment with the selective progesterone-receptor modulator ulipristal acetate was effective in controlling excessive bleeding and reducing fibroid size at 13 weeks. Uterine leiomyomas, or fibroids, are benign, hormone-sensitive, smooth-muscle tumors that occur in 20 to 40% of women of reproductive age. 1 , 2 The most common symptoms are menorrhagia and iron-deficiency anemia, which may lead to chronic fatigue 3 that may not be adequately controlled with iron supplementation alone. 4 – 6 Other symptoms include pelvic pain, dysmenorrhea, and pressure effects, which may adversely affect quality of life and fertility. 7 – 10 Many patients require intervention, and the choice of treatment is guided by the patient's age and desire to preserve fertility and avoid hysterectomy. 10 Fibroids are the most common indication for hysterectomy. 1 Other treatments include . . .

In this trial comparing oral ulipristal acetate (5 mg or 10 mg daily) with once-monthly leuprolide acetate in women with symptomatic uterine fibroids before planned surgery, both doses of ulipristal acetate were noninferior to leuprolide acetate in controlling uterine bleeding. Uterine leiomyomas, or fibroids, are the most common benign uterine tumors in women of reproductive age. In addition to anemia caused by heavy bleeding, fibroids can cause pelvic pain, pressure, dysmenorrhea, reduced quality of life, and infertility. Current management strategies consist mainly of surgical or radiologic interventions; options for medical therapy are limited. 1 – 4 The use of oral progestin has not been extensively investigated, but small studies report breakthrough bleeding 5 and possible promotion of myoma growth. 6 The use of a progestin-releasing intrauterine device controls menorrhagia in some patients, but trials have generally excluded patients with uteri distorted by submucosal myomas. . . .

A multicenter, randomized, open-label, phase III study was conducted to compare the efficacy and safety of intravenous ferric derisomaltose (FDI) versus saccharated ferric oxide (SFO) in Japanese patients with iron deficiency anemia associated with menorrhagia. FDI can be administered as a single dose up to 1000 mg, whereas SFO has a maximum single dose of 120 mg. The primary endpoint, which was the maximum change in hemoglobin concentration from baseline, was noninferior for the FDI group compared with the SFO group. The incidence of treatment-emergent adverse events was lower in the FDI group (66.2%) than in the SFO group (90.8%). Notably, the incidence of serum phosphorus level < 2.0 mg/dL was significantly lower in the FDI group (8.4%) than in the SFO group (83.2%), and severe hypophosphatemia (≤ 1.0 mg/dL) occurred in 6.7% of SFO‑treated patients compared with none in the FDI group. The percentage of patients who achieved the cumulative total iron dose during the 8-week treatment period was higher in the FDI group (92.8%) than in the SFO group (43.2%). The study met its primary endpoint, and also demonstrated the tolerability of a high dose of FDI per infusion, with a lower incidence of hypophosphatemia.

In this pragmatic, randomized trial of women with menorrhagia, the levonorgestrel-releasing intrauterine system was more effective than the usual (oral) medical treatment in reducing the effect of this problem on quality of life. Heavy menstrual bleeding, or menorrhagia, is a common problem that can have a significant effect on women's lives and can burden both patients and health care systems. 1 , 2 Menorrhagia accounts for 18.5% of gynecologist office visits in the United States 3 and for 20% in the United Kingdom 4 ; more than 5% of women who are 30 to 49 years of age consult family physicians each year in the United Kingdom with this problem. 5 Rates of surgical procedures for menorrhagia are 17.8 per 10,000 women 25 to 44 years of age in the United States 6 and 14.3 per 10,000 women 24 . . .

Background Uterine leiomyomas are the most common neoplasm affecting women and frequently cause heavy menstrual bleeding and pain. Gonadotropin-releasing hormone (GnRH) receptor antagonists provide fast symptom relief and show promise as a medical (non-surgical) treatment option and as a presurgical treatment to reduce leiomyoma size. The aim of this study was to evaluate the efficacy and safety of three dose levels of oral relugolix, a small molecule GnRH receptor antagonist, in Japanese women with uterine leiomyomas and heavy menstrual bleeding. Methods This phase 2, multicenter, double-blind, parallel-group study was conducted at 36 sites in Japan in women with uterine leiomyomas and heavy menstrual bleeding, defined as a pictorial blood loss assessment chart (PBAC) score of ≥ 120 in one menstrual cycle. Patients were randomized 1:1:1:1 to relugolix 10, 20, or 40 mg, or placebo, orally once daily for 12 weeks. The primary endpoint was the proportion of patients with a total PBAC score of < 10 from week 6 to 12. A sample size of 50 patients per group was estimated to provide ≥ 95% power, based on the comparison of relugolix 40 mg with placebo using a chi-square test with a significance level of 5% (two-sided). Results From November 2011 to September 2012, 216 patients were randomized and 214 patients (99.1%) were analyzed. The proportion (difference vs. placebo) of patients that achieved the primary endpoint in the placebo and 10-, 20-, and 40-mg relugolix groups were 0%, 20.8% (95% confidence interval [CI]: 9.3–32.3, P  < .001), 42.6% (95% CI: 29.4–55.8, P  < .001), and 83.3% (95% CI: 73.4–93.3, P  < .001), respectively. Though treatment-emergent adverse events were similar between the 20- and 40-mg groups, the incidence rates were more frequent compared with the placebo group. Most of these adverse events were mild or moderate in intensity. Conclusions Relugolix decreased menstrual blood loss in women with uterine leiomyomas in a dose–response manner, and was generally well tolerated. Clinical trial registration: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT01452659 , NCT01452659 (registered 17/10/2011); JAPIC Clinical Trial Information, https://www.clinicaltrials.jp , JapicCTI-111590 (registered 31/08/2011).

In India, heavy menstrual bleeding or menorrhagia (Raktapradara) constitutes about 15% to 20% of all gynecological admissions in an institution. Of these, 43% of patients are aged 20-40 years. This condition is worsening because of the high prevalence of anemia among Indian women. Menorrhagia can have a significant impact on women's lives. Medical treatment is usually the first choice in excessive bleeding, but it reduces menstrual blood loss by only 50%, and up to 50% of women undergo surgical treatment within 5 years. However, none of these treatments proved their definite efficacy in spite of the high price and side effects. This condition presents a major financial burden on health care services. In Ayurveda, encouraging work has been done on the compound drug Ashokarishta, and the drug Trinakantamani pishti is indicated in Ayurvedic classics and the Ayurvedic Formulary of India. Also, these medicines have been used in Ayurvedic practice for a long time. However, no clinical trial has been carried out on these formulations. The primary objective is to evaluate the efficacy of Ayurvedic intervention in the management of menorrhagia, and the secondary objective is to assess the efficacy of Ayurvedic intervention on the quality of life of the women with menorrhagia. This ongoing study is an open-label, interventional, randomized controlled trial, with a sample size of 140 in the treatment and control groups combined (including 20% dropouts), and will be carried out within the duration of 36 months. Participants in the treatment group will receive Ayurvedic treatment, that is, 20 mL of Ashokarishta, 250 mg of Trinakantamani pishti, and 1 iron and folic acid tablet (100 mg of elemental iron and 1.5 mg of folic acid) twice a day orally for 3 months. Participants in the control group will receive a 500-mg tranexamic acid tablet thrice a day for 7 days from the first day of menses for 3 cycles and 1 iron and folic acid tablet twice a day orally for 3 months. The primary outcomes are changes in the amount of uterine bleeding evaluated by the Pictorial Blood Loss Assessment Chart, changes in the duration of bleeding, and attainment of a normal quantity of blood loss during the interval of cycles. The secondary outcome is changes in the Menorrhagia Impact Questionnaire. As of December 2024, a total of 79 patients have been enrolled. Data analysis should be completed by February 2026. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publications in a relevant journal. The Ayurvedic approach may provide an evidence-based therapeutic tactic for the management of menorrhagia. Clinical Trial Registry India CTRI/2023/05/052929; https://tinyurl.com/3cd6mxrn. DERR1-10.2196/60801.

Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients' satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0-4] vs. 15 [0-131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100-100] vs. 100 [87-100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs.$2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089). For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. NCT01165307.

•Herbal medicines are being used as complementary or alternative therapies for management of heavy menstrual bleeding; however, scientific evidence supporting their efficacy is lacking.•Frankincense (Boswellia serata) and Ginger (Zingiber officinale) may be effective in the treatment of heavy menstrual bleeding considering their anti-inflammatory properties.•This randomized placebo-controlled trial shows that frankincense and ginger are effective complementary treatments for heavy menstrual bleeding and can reduce amount and duration of bleeding and improve quality of life of the patients. To evaluate the effect of frankincense (Boswellia serrata, oleoresin) and ginger (Zingiber officinale, rhizoma) as complementary treatments for heavy menstrual bleeding (HMB) among women of reproductive age. Randomized, placebo-controlled, clinical trial. Gynecology outpatient clinics. Patients with HMB (n = 102) were randomly assigned to three groups. All patients received ibuprofen (200 mg) and either frankincense (300 mg), ginger (300 mg), or a placebo, which contains 200 mg anhydrous lactose as the filling agent and was similar in appearance to the two other drugs. Patients received the medications three times a day for seven days of the menstrual cycle, starting from the first bleeding day and this was repeated for two consecutive menstrual cycles. Amount and duration of menstrual bleeding and quality of life (QOL). Duration of menstrual bleeding was decreased in the frankincense (−1.77 ± 2.47 days, P = 0.003) and ginger (−1.8 ± 1.79 days, P = 0.001) groups, but not in the placebo group (−0.52 ± 1.86 days, P = 0.42). Amount of menstrual bleeding was decreased in all (P < 0.05), with no difference among the study groups (P > 0.05). More improvement in QOL was observed in the frankincense (−25.7 ± 3.1; P < 0.001) and ginger (−29.2 ± 3.7: P < 0.001) groups compared to the placebo group (−15.07 ± 3.52; P < 0.001) and between the groups, differences were statistically significant (P = 0.02). Ginger and frankincense seem to be effective complementary treatments for HMB. Further studies with a larger sample size and longer follow-up are warranted in this regard.