CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 11:24:31 GMT)

CTRI Number CTRI/2015/10/006289 [Registered on: 21/10/2015] - Trial Registered Retrospectively Last Modified On 20/10/2015 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group Trial Public Title of Study Efficacy of ormeloxifene in uterine fibroids compared to oral contraceptives Scientific Title of To compare the efficacy of ormeloxifene versus oral contraceptive pills in medical management of Study menorrhagia due to uterine myomas Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Alka Kriplani Trial Coordinator (multi-center study) Designation Professor Affiliation All india institute of Medical Sciences, New Delhi Address Room No. 3078, Teaching Block, 3rd Floor, Dept. of Obstetrics and Gynaecology, AIIMS, New Delhi New Delhi DELHI 110029 India Phone 911-26594933 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Astha Srivastava Query) Designation PG student Affiliation All india institute of Medical Sciences, New Delhi Address Room No. 3078, 3rd Floor, Teaching Block, dept of Obstetrics and Gynaecology New Delhi DELHI 110029 India Phone 91-9899847641 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Alka Kriplani Designation Professor Affiliation All india institute of Medical Sciences, New Delhi Address Room No. 3078, Teaching Block, 3rd Floor, Dept. of Obstetrics and Gynaecology, AIIMS, New Delhi New Delhi DELHI 110029 India Phone 911-26594933

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Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > AIIMS Primary Sponsor Primary Sponsor Details Name All India institute of medical Sciences New Delhi Address Room No. 3078, Teaching block, Dept. of Obstetrics and Gynaecology, AIIMS, New Delhi-110029 Type of Sponsor Research institution and hospital Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Alka kriplani AIIMS, New Delhi Room no. 2, Gynae 011-26594933 OPD, 3rd Floor, OPD Block. AIIMS [email protected] New Delhi DELHI Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethics Committee, Approved 05/06/2012 No AIIMS, Ansari Nagar, New Delhi Regulatory Clearance Status Date Status from DCGI Approved/Obtained 06/11/2012 Health Condition / Health Type Condition Problems Studied Patients Patients presenting with menorrhagia due to uterine myomas Intervention / Type Name Details Comparator Agent Intervention Ormeloxifene Ormeloxifene is a Selective Estrogen receptor modulator, which was given in the dose of 60 mg twice weekly for 6 months Comparator Agent Novelon Oral contraceptive pill containing Ethinyl Estradiol 30 mcg with Desogestrel 150 mg From Day 1 to day 21 of cycle for 6 months Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 45.00 Year(s) Gender Female Details Patients presenting with menorrhagia due to uterine myomas with intramural or subserosal myomas on ultrasound or submucosal grade 2 myomas on hysteroscopy Exclusion Criteria Exclusion Criteria Details Patients with more than 16 weeks gravid size uterus, submucosal

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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 Method of Generating Computer generated randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints 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 Outcome Timepoints Bleeding days, cycle length, VAS score for End of 1st, 3rd and 6th month during treatment dysmenorrhoea, Myoma volume, side effect, and at 3 months after stopping treatment, haemoglobin hemoglobin after 6 months of treatment Target Sample Size Total Sample Size=50 Sample Size from India=50 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 3 Date of First 03/11/2010 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details The study will be sent for publication after CTRI registration 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)

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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.

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