camparative study of safety and efficacy of Medroxyprogesterone acetate and ormeloxifene in women with Abnormal uterine bleeding: An observational study

Not Applicable

Completed

Conditions: Diseases of the genitourinary system,

Registration Number: CTRI/2019/01/017230

Lead Sponsor: SKIMS Medical College and Hospital

Brief Summary: Abnormal uterine bleeding (AUB) is responsible for significant health problem and social embarrassment and it is one of the common reasons women seek health care. It has a significant impact on the quality of life for the women. Women with abnormal bleeding have a lower quality of life than the general female population **(NPH).**

AUB is a significant clinical entity. AUB and its sub group, heavy menstrual bleeding (HMB), are common conditions affecting 14â€“25% of women of reproductive age **(Fraser et al, 2009)** and may have a significant impact on their physical, social, emotional and quality of life.

In the UK, over 800,000 women seek help for AUB annually **(NICE 2007).**

The prevalence varies in each country. In India, the reported prevalence of AUB is around **17.9% (NPH).**

Because of the morbidity associated with the surgical procedures, the [Royal College of Obstetricians and Gynaecologists](https://www.rcog.org.uk/) RCOG recommends beginning with medical management before resorting to surgical interventions, but medical management of AUB should relieve symptoms, improve quality of life and avoid the risk of surgery.

Ormiloxifene (SERM) is finding a promising role in the treatment and management of AUB. Ormeloxifene has a good patient acceptability and compliance due to its minimal side effects, low cost and simple dosage schedule than that of Medroxyprogesterone (MPA).This study will furnish the necessary information about the use of Ormiloxifene.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 240

Inclusion Criteria

All patients diagnosed with AUB attending the OPD/or for consultation in the Obstetrics and Gynaecology department of SKIMS Medical College and Hospital, Bemina, Srinagar will be enrolled during the study period.

Exclusion Criteria

Patients with leiomyoma, adenomyosis, polyp, adnexal mass.
Patients with systemic disorder.
Patients with coagulopathy Patients with breast malignancy Patients with endometrial hyperplasia.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectively	AFTER 4 MONTHS

Secondary Outcome Measures

Name	Time	Method
to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectively	monthly follow up upto 4 months

Trial Locations

Locations (1): SKIMS MEDICAL COLLEGE AND HOSPITAL BEMINA SRINAGAR
🇮🇳
JAMMU, & KASHMIR, India
SKIMS MEDICAL COLLEGE AND HOSPITAL BEMINA SRINAGAR
🇮🇳JAMMU, & KASHMIR, India
Suhail Ahmad Mir
Principal investigator
7006270349
suhailmir.scholar@kashmiruniversity.net