Ormeloxifene can be drug of choice in patients with heavy menstrual bleeding, suggests study
Menorrhagia is one of the commonest menstrual dysfunction, affecting 10-33% of women at some stage of their lives; besides being major cause of iron deficiency anemia in females after nutritional anaemia. Menorrhagia is described as heavy bleeding that occurs in cycles at regular intervals and lasts more than seven days, or more than 80 milliliters of blood loss. A variation in regularity, frequency, duration and amount of blood loss from the normal menstrual cycle without any clinically detectable organic, systemic and iatrogenic cause, is defined as Heavy Menstrual Bleeding and is a diagnosis of exclusion. To reduce symptoms and improve quality of life, treatment options for HMB vary from medical to surgical treatments, however the RCOG advice starts with medical care. Oral or intramuscular progesterone, levonorgestrel intrauterine system (LNG-IUS), anti-fibrinolytic agents like tranexamic acid, gonadotropins releasing hormone, and combined oral contraceptives pills are some available medical options.
Ormeloxifene, a third-generation selective estrogen receptor modulator (SERM), is a non-steroidal, nonhormonal oral contraceptive known as SAHELI. It functions by exerting anti-estrogenic effects onuterine and breast tissue, reducing the risk of endometrial and uterine cancer. Conversely, it exhibits estrogenic effects on the vagina, bones, cardiovascular system, and central nervous system, thereby addressing issues like vaginal dryness, bone loss, and high cholesterol levels, making it particularly advantageous for perimenopausal women.
60 mg of ormeloxifene is administered twice a week for the first three months and then once a week for the following three. The medication has a half-life of 170 hours and is metabolized in the liver. The uterus has the highest drug concentration, second only to the liver. Hepatic dysfunction, pregnancy, lactation, chronic disease, and PCOS are common contraindications. Weight gain, vomiting, and nausea are typical adverse effects. The aim and objective of the present study was to determine the therapeutic efficacy and efficiency of SERMS in management of HMB in perimenopausal women.
An institution based prospective study was conducted on 150 patients in the age group of 35-45 years who were treated with 60mg ormeloxifene twice a week for the first 3 months and once weekly for the next 3 months. The outcome was assessed based on menstrual blood loss in terms of PABC score, endometrial thickness and hemoglobin concentration.
The treatment effects of ormeloxifene, in patients of Heavy Menstrual bleeding was found PBAC score decreased to 95 ± 28.35 in 6 months from the basal value of 244.15 ± 35.04. endometrial thickness (in mm) decreased to 6.70 ± 1.22 at 6 months, from the basal value of 9.57± 1.15 (mm). Haemoglobin levels increased to 9.57 ± 0.84 at 6 months from the basal value of 7.52 ± 0.75(gm/dl).
On average, the length of the menstrual cycle varies from 21– 35 days, blood flow occurs for 2–7 days, and blood loss occurs for 20–80 milliliters per cycle. Uterine bleeding that deviates from this typical in both quantity and duration is known as dysfunctional uterine hemorrhage. We observed in our study how ormeloxifene medication affected endometrial thickness, hemoglobin, and PBAC score in individuals with dysfunctional uterine hemorrhage.
Ormeloxifene may be the medication of choice for individuals with HMB based on these findings because it is extremely safe, reasonably priced, and has tolerable side effects. This straightforward medication-based therapy has improved patient compliance, tolerability, and treatment adherence due to a discernible decrease in symptoms. Additionally, it lowers the risk of breast cancer because of its anti-estrogen impact on breast tissue. It is particularly a better option for patients who are at high risk of surgery, young women who want to use contraception, and perimenopausal women to get through that time and embrace amenorrhea. Among all the conservative methods for the medical management of menorrhagia, one of the most effective and safest medications is ormeloxifene. Surgical treatments are the last resort in the event that medical care, which has always been the first therapeutic alternative considered, is ineffective. Thus may be regarded as the initial course of treatment for HMB patients.
Source: Kulkarni et al. / Indian Journal of Obstetrics and Gynecology Research 2025;12(3):415–418
