Effects of ospemifene, a novel SERM, on hormones, genital tract, climacteric symptoms, and quality of life in postmenopausal women: a double-blind, randomized trial

Abstract Background Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. Methods The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. Discussion This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853. EudraCT: 2017-003144-21; registered: 24-07-2017.

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The Effectiveness of Melissa Officinalis L. versus Citalopram on Quality of Life of Menopausal Women with Sleep Disorder: A Randomized Double-Blind Clinical Trial

Revista Brasileira de Ginecologia e Obstetrícia / RBGO Gynecology and Obstetrics ◽

10.1055/s-0040-1721857 ◽

2021 ◽

Author(s):

Mahboobeh Shirazi ◽

Mohamad Naser Jalalian ◽

Masoumeh Abed ◽

Marjan Ghaemi

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Sleep Disturbance ◽

Postmenopausal Women ◽

Melissa Officinalis ◽

Foeniculum Vulgare ◽

Double Blind ◽

Menopausal Women ◽

The Mean

Abstract Objective The present study aimed to assess the effect of Melissa Officinalis L. (a combination of lemon balm with fennel fruit extract) compared with citalopram and placebo on the quality of life of postmenopausal women with sleep disturbance. Methods The present study is a randomized, double-blind, placebo clinical trial among 60 postmenopausal women with sleep disturbance who were referred to a university hospital from 2017 to 2019. The participants were randomized to receive M. Officinalis L. (500 mg daily), citalopram (30 mg) or placebo once daily for 8 weeks. The Menopause-Specific Quality of Life (MENQOL) questionnaire was self-completed by each participant at baseline and after 8 weeks of the intervention and was compared between groups. Results The mean for all MENQOL domain scores were significantly improved in the M. Officinalis L. group compared with citalopram and placebo (p < 0.001). The mean ± standard deviation (SD) after 8 weeks in the M. Officinalis L., citalopram and placebo groups was 2.2 ± 0.84 versus 0.56 ± 0.58 versus 0.36 ± 0.55 in the vasomotor (p < 0.001), 1.02 ± 0.6 versus 0.28 ± 0.2 versus 0.17 ± 0.1 in the psychomotor-social (p < 0.001), 0.76 ± 0.4 versus 0.25 ± 0.1 versus 0.11 ± 0.1 in the physical and 2.3 ± 1.0 versus 0.35 ± 0.5 versus 0.41 ± 0.5 in the sexual domain, respectively. Conclusions The results revealed that M. Officinalis L. may be recommended for improving the quality of life of menopausal women with sleep disturbance. Trial registration The present study was registered by the name “Comparison of the efficacy of citalopram and compound of Asperugo procumbens and foeniculum vulgare in treatment of menopausal disorders” with the code IRCT2013072714174N1 in the Iranian Registry of Clinical Trials (IRCT).

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Effect of soy isoflavones supplement on climacteric symptoms, bone biomarkers, and quality of life in Korean postmenopausal women: a randomized clinical trial

Nutrition Research and Practice ◽

10.4162/nrp.2017.11.3.223 ◽

2017 ◽

Vol 11 (3) ◽

pp. 223 ◽

Cited By ~ 11

Author(s):

Hansongyi Lee ◽

Ryowon Choue ◽

Hyunjung Lim

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Postmenopausal Women ◽

Randomized Clinical Trial ◽

Soy Isoflavones ◽

Bone Biomarkers ◽

Climacteric Symptoms

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A randomized, double-blind, multiple-dose escalation study of a Chinese herbal medicine preparation (Dang Gui Buxue Tang) for moderate to severe menopausal symptoms and quality of life in postmenopausal women

Menopause The Journal of The North American Menopause Society ◽

10.1097/gme.0b013e318267f64e ◽

2013 ◽

Vol 20 (2) ◽

pp. 223-231 ◽

Cited By ~ 23

Author(s):

Chi Chiu Wang ◽

King Fai Cheng ◽

Wing Man Lo ◽

Cindy Law ◽

Lu Li ◽

...

Keyword(s):

Quality Of Life ◽

Herbal Medicine ◽

Postmenopausal Women ◽

Chinese Herbal Medicine ◽

Dose Escalation ◽

Multiple Dose ◽

Dose Escalation Study ◽

Double Blind ◽

Chinese Herbal

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Quality of life of postmenopausal women on a regimen of transdermal estradiol therapy: A double-blind placebo-controlled study

American Journal of Obstetrics and Gynecology ◽

10.1016/s0002-9378(12)90828-5 ◽

1993 ◽

Vol 168 (3) ◽

pp. 824-830 ◽

Cited By ~ 179

Author(s):

Ingela Wiklund ◽

Johan Karlberg ◽

Lars-Åke Mattsson

Keyword(s):

Quality Of Life ◽

Postmenopausal Women ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Transdermal Estradiol

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Continuous combined hormone replacement therapy relieves climacteric symptoms and improves health-related quality of life in early postmenopausal women

Menopause International: The Integrated Journal of Postreproductive Health ◽

10.1258/175404507781605622 ◽

2007 ◽

Vol 13 (3) ◽

pp. 116-123 ◽

Cited By ~ 9

Author(s):

Joan Pitkin ◽

Vera Petrovna Smetnik ◽

Péter Vadász ◽

Mika Mustonen ◽

Kaisa Salminen ◽

...

Keyword(s):

Quality Of Life ◽

Hormone Replacement Therapy ◽

Postmenopausal Women ◽

Hormone Replacement ◽

Health Related Quality ◽

Climacteric Symptoms ◽

Early Postmenopausal Women ◽

Related Quality ◽

Health Related

Objective. Hormone replacement therapy (HRT) relieves menopausal symptoms but its effect on health related quality of life (HRQoL) is uncertain. The aim of this study was to assess the effect of three dose regimens of continuous combined HRT, consisting of estradiol valerate (E2V) and medroxyprogesterone acetate (MPA) on HRQoL in early postmenopausal women (last menstrual period 1–3 years before study entry). Study design. This was a 52-week, randomized, double-blind, multinational study comparing E2V (1 mg or 2 mg) plus MPA (2.5 mg or 5 mg) in different dose combinations. The intention-to-treat population comprised 459 women (average age 51.5 years). Main outcome measures. HRQoL was assessed by the Women's Health Questionnaire (WHQ), the 15D Questionnaire and a visual analogue scale (VAS). Results. There were improvements on eight of the nine domains of the WHQ with all dose regimens during the first 12 weeks ( P<0.0001) and an improvement in the remaining domain (menstrual symptoms) with the lower-dose regimens ( P<0.05). These initial improvements in HRQoL were then maintained or augmented over the remainder of the study ( P<0.0001 for change from baseline at 52 weeks for all domains and dose regimens). Mean 15D total score had improved meaningfully and significantly by 12 weeks ( P<0.0001 versus baseline) in all treatment groups and this improvement was maintained thereafter. This improvement in 15D total score was most marked among previous non-users of HRT ( P<0.05 versus previous users). VAS scores recorded significant ( P<0.05) reductions in hot flushes, sweating and sleep disturbances in all groups after week 1 and highly significant ( P<0.0001) relief of all climacteric symptoms at week 52. Conclusion. Continuous combined HRT was associated with pronounced improvement of vasomotor symptoms and HRQoL in this population of early postmenopausal women.

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