Efficacy of ormeloxifene in uterine fibroids compared to oral contraceptives

Phase 3

Completed

• Conditions: Patients presenting with menorrhagia due to uterine myomas

• Registration Number: CTRI/2015/10/006289
• Lead Sponsor: All India institute of medical Sciences New Delhi

Brief Summary

**Objective**: To compare efficacy of ormeloxifene (Selective Estrogen Receptor Modulator) versus combined oral contraceptive pills (novelon) in medical management of menorrhagia due to uterine myomas.

**Methods**: Fifty women with menorrhagia due to myomas were recruited after taking informed consent and institute’s ethical clearance. Group-I (n=25) was given ormeloxifene 60mg twice weekly & group-II (n=25) was given combined oral contraceptive pills (novelon) from day 1 to 21 of menstrual cycle for 6 months. Menstrual blood loss was assessed by pictorial blood loss assessment chart (PBAC) score, myoma related symptoms like dysmenorrhoea were assessed by Visual Analogue Scale (VAS) and myoma volume was assessed by ultrasound.   Follow ups were done at 1, 3, 6 and 9 months. Haemoglobin was assessed at baseline, at 6 months and 9 months follow up.

**Results**: Mean baseline PBAC score reduced significantly in both groups at all follow ups. Reduction was greater with ormeloxifene. Myoma volume increased at sixth month in both the groups (p>0.05 in both groups). Seven (28%) developed ovarian cysts in group-I which disappeared after discontinuing treatment. No major adverse effect was seen in either group.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-11
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Patients presenting with menorrhagia due to uterine myomas with intramural or subserosal myomas on ultrasound or submucosal grade 2 myomas on hysteroscopy.

Exclusion Criteria

Patients with more than 16 weeks gravid size uterus, submucosal myomas of grade 0 or 1 on hysteroscopy, atypia on endometrial histopathology, concurrent ovarian pathology, history or currently suffering from thromboembolic disease, smokers more than 35 years age, hypertension or with history of taking hormonal treatment within 3 months of treatment initiation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PBAC Score to assess menstrual blood loss	End of 1st, 3rd and 6th month during treatment and at 3 months after stopping treatment

Secondary Outcome Measures

Name	Time	Method
Bleeding days, cycle length, VAS score for dysmenorrhoea, Myoma volume, side effect, haemoglobin	End of 1st, 3rd and 6th month during treatment and at 3 months after stopping treatment, hemoglobin after 6 months of treatment

Trial Locations

Locations (1)

AIIMS, New Delhi; 🇮🇳 Delhi, DELHI, India

AIIMS, New Delhi

🇮🇳Delhi, DELHI, India

Dr Alka kriplani

Principal investigator

011-26594933

kriplanialka@gmail.com