{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T04:12:29Z","timestamp":1790223149402,"version":"4.1.0"},"reference-count":35,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2022,10,22]],"date-time":"2022-10-22T00:00:00Z","timestamp":1666396800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002383","name":"King Saud University: Riyadh, Saudi Arabia and The APC was funded by RSP","doi-asserted-by":"publisher","award":["RSP-2021\/115"],"award-info":[{"award-number":["RSP-2021\/115"]}],"id":[{"id":"10.13039\/501100002383","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Medicina"],"abstract":"<jats:p>Background and objectives: Abnormal uterine bleeding is a significant clinical and gynaecological concern that necessitates its safe and effective treatment. The present study aims to compare the cost-effectiveness, safety, efficacy, and health-related quality of life of ormeloxifene with medroxyprogesterone acetate in women with non-structural abnormal uterine bleeding. Materials and Methods: A prospective, randomized, single-blinded clinical trial of 367 patients was carried out at a tertiary care hospital for a period of one year from 5 January 2019 to 4 January 2020. Patients were randomized into two groups for administering ormeloxifene and medroxyprogesterone acetate for a 3-month treatment duration and were evaluated by laboratorial investigations like anaemic status, bleeding duration, endometrial thickness, pictorial blood loss assessment chart (PBLAC) score, and patient\u2019s medical and medication history. Health-related quality of life was assessed using short form survey-36 (SF-36) questionnaire scale. Cost-effectiveness was determined on the basis of the three-month treatment regimen. Results: The mean duration of bleeding reduced from 16.88 \u00b1 6.46 to 7.76 \u00b1 1.55 in the ormeloxifene group and from 15.91 \u00b1 5.04 to 8.7 \u00b1 1.91 (p &lt; 0.001) in the medroxyprogesterone acetate. Similarly, mean haemoglobin increased from 8.56 \u00b1 0.77 to 10.1 \u00b1 0.087 g\/dL and from 8.60 \u00b10.97 to 9.551 \u00b1 0.90 g\/dL (p &lt; 0.001), and endometrial thickness showed a reduction from 8.52 \u00b1 1.61 mm to 6.92 \u00b1 1.68 mm and from 8.40 \u00b1 2.09 mm to 7.85 \u00b1 2.0 mm (p &lt; 0.001) in the ormeloxifene and medroxyprogesterone acetate groups, respectively. PBLAC score reduced from 289.92 \u00b1 42.39 to 128.11 \u00b1 33.10 and from 287.38 \u00b1 40.94 to 123.5 \u00b1 29.57 (p &lt; 0.001) in these groups, respectively. Health-related quality of life improved in the ormeloxifene group more than the medroxyprogesterone group, which was evidenced by SF-36 scale parameters (physical function, energy\/fatigue and pain) that changed from 24.39, 12.99, 6.25 to 28.95, 18, 9 and from 25.41, 13.6, 7.1 to 27.02, 16, 8.3 in the ormeloxifene and medroxyprogesterone acetate groups, respectively. Conclusions: The study concludes that both medroxyprogesterone acetate and ormeloxifene are safe and efficacious in controlling abnormal uterine bleeding, but ormeloxifene was the better of the two in terms of cost effectiveness, reduction in pictorial blood loss assessment score, endometrial thickness, bleeding duration (days), increase in haemoglobin concentration (g\/dL) and improvement in the quality of life.<\/jats:p>","DOI":"10.3390\/medicina58111503","type":"journal-article","created":{"date-parts":[[2022,10,24]],"date-time":"2022-10-24T06:37:45Z","timestamp":1666593465000},"page":"1503","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Evaluation of the Safety and Efficacy of Ormeloxifene, a Selective Estrogen Receptor Modulator and Medroxyprogesterone Acetate in Women with Non-Structural Abnormal Uterine Bleeding: A Randomized Clinical Trial"],"prefix":"10.3390","volume":"58","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3968-8434","authenticated-orcid":false,"given":"Suhail Ahmad","family":"Mir","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences, University of Kashmir, Hazratbal, Srinagar 190006, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rifat","family":"Ara","sequence":"additional","affiliation":[{"name":"Department of Obstetrics & Gynaecology, Sher-I-Kashmir Institute of Medical Sciences, Medical College & Hospital, Srinagar 190001, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiza","family":"Amin","sequence":"additional","affiliation":[{"name":"Department of Gynaecology and Obstetrics, Lala Ded Hospital, Government Medical College, Srinagar 190006, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anjum","family":"Malik","sequence":"additional","affiliation":[{"name":"Department of Obstetrics & Gynaecology, Sher-I-Kashmir Institute of Medical Sciences, Medical College & Hospital, Srinagar 190001, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2185-5927","authenticated-orcid":false,"given":"Laraibah","family":"Hamid","sequence":"additional","affiliation":[{"name":"Department of Zoology, University of Kashmir, Hazratbal, Srinagar 190006, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tabasum","family":"Ali","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, University of Kashmir, Hazratbal, Srinagar 190006, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6820-0805","authenticated-orcid":false,"given":"Ghulam Nabi","family":"Bader","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, University of Kashmir, Hazratbal, Srinagar 190006, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9860-0124","authenticated-orcid":false,"given":"Shahid Ud Din","family":"Wani","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, University of Kashmir, Hazratbal, Srinagar 190006, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mansour","family":"Almuqbil","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0922-9819","authenticated-orcid":false,"given":"Sultan","family":"Alshehri","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulhakeem M.","family":"Alshehri","sequence":"additional","affiliation":[{"name":"Supply Department, Armed Forces Aeromedical Center, Dhahran 31932, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faiyaz","family":"Shakeel","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,10,22]]},"reference":[{"key":"ref_1","first-page":"1","article-title":"Association of dysfunctional uterine bleeding with high body mass index and obesity as a main predisposing factor","volume":"8","author":"Nouri","year":"2014","journal-title":"Diab. 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