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Efficacy and safety of ormeloxifene in management of menorrhagia: A pilot study
Author(s) -
Kriplani Alka,
Kulshrestha Vidushi,
Agarwal Nutan
Publication year - 2009
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/j.1447-0756.2008.00987.x
Subject(s) - medicine , visual analogue scale , hysterectomy , amenorrhea , adverse effect , blood loss , surgery , gynecology , pregnancy , genetics , biology
Objective: To assess the efficacy and safety of ormeloxifene (centchroman) in the medical management of menorrhagia. Methods: Forty‐two women with menorrhagia were recruited for the study. Ormeloxifene was given to each patient 60 mg twice a week for 3 months and then once a week for 1 month. Patients were followed up at 2 and 4 months of therapy, then at 3 and 6 months after treatment was stopped. Menstrual blood loss (MBL) was measured objectively by a pictorial blood loss assessment chart (PBAC) score and subjectively by a visual analog scale (VAS). Results: The pretreatment median PBAC score was 388 (range 169–835). Eighteen patients (42.9%) had amenorrhea with the therapy. Median PBAC reduced to 80 (range 0–730) and 5 (range 0–310) at 2 and 4 months, respectively ( P ‐value <0.001); thus, the percentage reduction was 97.7% at 4 months. Seven patients (16.7%) had no response and three (7.1%) discontinued treatment before 4 months. During the 10‐month study period, 21% of the patients underwent hysterectomy. Adverse effects included ovarian cyst (7.1%), cervical erosion and discharge (7.1%), gastric dyspepsia (4.8%), vague abdominal pain (4.8%) and headache (4.8%). Conclusion: Ormeloxifene is an effective and safe therapeutic option for the medical management of menorrhagia.