| 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 Study
|
To compare the efficacy of ormeloxifene versus oral contraceptive pills in medical management of menorrhagia due to uterine myomas |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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 |
| Fax |
|
| Email |
kriplanialka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Astha Srivastava |
| 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 |
astha1402@gmail.com |
|
Details of Contact 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 |
| Fax |
|
| Email |
kriplanialka@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| 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 Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alka kriplani |
AIIMS, New Delhi |
Room no. 2, Gynae OPD, 3rd Floor, OPD Block. AIIMS
New Delhi
DELHI |
011-26594933
kriplanialka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, AIIMS, Ansari Nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients presenting with menorrhagia due to uterine myomas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| 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 |
| Intervention |
Ormeloxifene |
Ormeloxifene is a Selective Estrogen receptor modulator, which was given in the dose of 60 mg twice weekly for 6 months |
|
|
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
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 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 |
|
|
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 Enrollment (India)
|
03/11/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The study will be sent for publication after CTRI registration |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |