Incidence Of Uterine Bleeding Research Articles

Incidence of Uterine Bleeding Following Oral Anticoagulant Use in FDA’s Sentinel System

(Abstracted from Am J Obstet Gynecol 2020; doi: 10.1016/j.ajog.2020.11.034) The aim of this study was to improve the understanding among clinicians of uterine bleeding (UB) events requiring intervention among women treated with an oral anticoagulant (OAC) therapy. The authors examined the incidence of UB events in the US Food and Drug Administration's (FDA's) Sentinel System, a database that comprised medical encounter and outpatient pharmacy claims data contributed by 17 public and commercial health insurers and integrated delivery networks.

Initiation of GnRH agonist treatment on 3-5 days postoperatively in endometriosis patients: a randomized controlled trial.

Seventy patients with stage III or IV endometriosis were randomly assigned to 2 groups after conservative surgery. Group O (n = 35) received 3 cycles of a 28-day gonadotropin-releasing hormone agonist (GnRH-a) treatment (goserelin, 3.6 mg) starting 3-5 days postoperatively. Group M (n = 35) received the same treatment starting on days 1-5 of menstruation. Groups were further subdivided according to add-back treatment. Pre- and posttreated levels of estradiol (E2 ), follicle stimulating hormone (FSH), and luteinizing hormone (LH) and visual analog scale (VAS), Kupperman menopausal index (KMI), and bone mineral density (BMD) scores were recorded. The incidence of uterine bleeding was assessed. In both groups, serum levels of E2 , FSH, and LH and VAS scores decreased significantly after treatment. Spotting was the most frequent bleeding pattern. During cycle 1, the bleeding time in group M was much longer that than that in group O (P =.001), and the bleeding rate in group M was significantly higher than that in group O (P =.024, RR = 1.185). In patients with stage III or IV endometriosis, the efficacy of GnRH-a initiated 3-5 days postoperatively was equivalent to that of GnRH-a initiated on days 1-5 of menstruation. Female patients who initiated GnRH-a treatment 3-5 days postoperatively experienced less uterine bleeding during the first cycle of treatment.

Randomized placebo- and active-controlled study of desvenlafaxine for menopausal vasomotor symptoms

ABSTRACTObjective To evaluate the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) vs. tibolone and placebo for menopausal vasomotor symptoms and the incidence of uterine bleeding.Methods This 12-week, double-blind, randomized, controlled trial was conducted at 35 sites in Europe, two sites in South Africa, and one site in Mexico. Postmenopausal women with ≥50 moderate or severe hot flushes per week (n = 485) were randomized to desvenlafaxine 100 mg/day, tibolone 2.5 mg/day, or placebo. Reduction in the average daily number of moderate and severe hot flushes at weeks 4 and 12 (primary endpoint) was evaluated using analysis of covariance. Safety assessments included incidence of uterine bleeding, adverse events, laboratory values, and vital signs.Results At week 12, no statistically significant difference was observed in reduction of the average daily number of moderate and severe hot flushes for desvenlafaxine (−5.78) vs. placebo (−5.82; p = 0.921), although time to 50% reduction was significantly less than placebo (13 vs. 26 days, p = 0.006). Hot flush reduction with tibolone (−8.21) was significantly greater than placebo (p < 0.001). Nausea was the most common adverse event with desvenlafaxine, was generally mild to moderate, and resolved within the first 2 weeks. Significantly more subjects experienced bleeding with tibolone (23%) vs. desvenlafaxine (12%; p < 0.024) or placebo (9%; p < 0.001).Conclusions Desvenlafaxine did not separate from placebo in reducing the number of moderate to severe hot flushes at week 12, although it did allow women to achieve 50% reduction sooner than placebo. Tibolone did separate from placebo, but with smaller than expected effect. The placebo effect was high (57%). Adverse drug reactions were consistent with the known safety profile of desvenlafaxine, and significantly more women who received tibolone experienced episodes of bleeding compared with women who received desvenlafaxine or placebo.

Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women

To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women. International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1). Outpatient clinical. Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus. Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo. Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years. Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (>83% during cycles 1-13 and >93% during cycles 10-13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects. Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile.

Phytotherapy versus hormonal therapy for postmenopausal bone loss: a meta-analysis

This meta-analysis included 14 randomized controlled trials involving 780 patients to compare phytotherapy with hormonal therapy in the treatment of postmenopausal bone loss. Current evidence suggests that phytotherapy may possess a similar effect on bone mineral density (BMD) values but clinically is not associated with a high incidence of uterine bleeding and breast pain as is hormonal therapy. Clinical trials indicate that phytotherapy may be a potential treatment for postmenopausal osteoporosis. The objective of this meta-analysis was to compare the efficacy and safety of phytotherapy with that of hormonal therapy, to assess the quality of phytotherapy trials, and to identify herbs used commonly in the treatment of postmenopausal bone loss. A total of 43 electronic databases were searched. The quality of eligible trials was assessed using Jadad's scale. Outcome measures were BMD values and adverse events. Revman 5.0 software was used for data syntheses and meta-analyses. The database search revealed 14 randomized controlled trials involving 780 patients that met the inclusion criteria, and four trials were graded as high quality (score 3-5). There was no significant difference in lumbar, femoral or forearm BMD values between subjects treated with phytotherapy and those treated with hormonal therapy (P>0.05), but the incidence of uterine bleeding and breast pain was significantly lower in those treated with phytotherapy than in those treated with hormonal therapy (P = 0.002 and P = 0.01). The six most commonly used herbs in the included trials were identified. Phytotherapy may not show effects beyond hormonal therapy, but may be safer than hormonal therapy in the treatment of postmenopausal bone loss. Further trials with high-quality study designs should be conducted in this field.

Raloxifene: A Selective Estrogen-Receptor Modulator for Postmenopausal Osteoporosis – a Clinical Update on Efficacy and Safety

Selective estrogen-receptor modulators are molecules with specific estrogen-receptor binding affinity. Each selective estrogen-receptor modulator induces a unique conformation in the ligand-receptor complex, which leads to transcriptional activation and/or inhibition. Raloxifene 60 mg/day, a benzothiophene selective estrogen-receptor modulator, is approved for the prevention and treatment of postmenopausal osteoporosis. This article provides an update on new studies and further analyses of clinical trial data for raloxifene. The Multiple Outcomes of Raloxifene Evaluation (MORE) trial of women with osteoporosis has described the efficacy of raloxifene in decreasing vertebral fracture risk over 4 years. The Continuing Outcomes Relevant to Evista((R)) (CORE) trial, designed to assess the effects of raloxifene on breast cancer prevention, is a 4-year continuation of MORE. The skeletal and cardiovascular effects of raloxifene in the CORE study were similar to those observed in MORE. The relative risk of developing breast cancer was significantly decreased in women treated with raloxifene, compared with placebo, after 4 years in MORE and 8 years in the CORE trial. The incidence of uterine bleeding, endometrial hyperplasia and endometrial cancer was similar between raloxifene and placebo after 8 years of treatment. Raloxifene use is associated with a higher incidence of hot flashes and leg cramps, and an increased risk of venous thromboembolic events.

Estradiol + norethisterone HRT has low incidence of uterine bleeding

Estradiol + norethisterone HRT has low incidence of uterine bleeding

Estradiol + norethisterone HRT has low incidence of uterine bleeding

Estradiol + norethisterone HRT has low incidence of uterine bleeding

Transfer factor (diffusing capacity) for the lung in simple pneumoconiosis of coal workers.

The incidence of uterine bleeding and menstrual cycle modi fications in women receiving oral continuous chlormadinone acetate in microdoses is significant. In our experience 153 (39.2 %) out of 390 women presented some alterations in uterine bleeding while using this contraceptive method; amenorrhoea, for instance, was observed in 15 % of our subjects. However, the modifications of menstrual cycles were slightly less frequent (in 147 (37.6%) out of 390 treated subjects). The most annoying symptoms indeed were amenorrhoea, pro longed cycles, and intermenstrual bleeding. These alterations are apparently related to the anti oestrogenic effect of the progestogen and are shown by those subjects more sensitive to such action. Furthermore, our macroscopic and microscopical observations on ovaries of subjects treated with 0.5 mg. of chlormadinone daily, who presented prolonged menstrual cycles or amenorrhoea, showed that ovulation was inhibited. A marked effect of the compound at the endometrium stroma and glands was also evident (Zaflartu et al., 1967b). These findings help us to understand why additional oestrogen therapy given for a few days for bleeding and cycle regulation could eventually reverse the effect in cervical mucus of chlormadinone 0.5 mg. daily, and yet preserve the main contraceptive effect of the therapy at other levels of the repro ductive system (endometrium, endosalpinx). The gratifying action of the accessory oestrogens by correct ing uterine bleeding and regulating cycles significantly helps to improve the acceptability of this valuable contraceptive method. It has also been valuable in improving the accept ability of other progestogens in microdosage. Summary