Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201801002953256 Date of Approval: 09/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title use of clomid in control of DMPA bleeding
Official scientific title Clomiphene citrate as a new modality in management of bleeding with depomedroxyprogesterone acetate (DMPA)
Brief summary describing the background and objectives of the trial DMPA causes irregular uterine bleeding due to unknown cause mostly due to endometrial atrophy. clomiphene citrate, CC, could be used to control such bleeding the objective is to asses the effectiveness of CC to stop bleeding in DMPA compared to placebo
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied contraceptive bleeding,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 30/08/2017
Actual Last follow-up date 30/08/2017
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 200
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
2017-1-155 medical ethical committe
nil known 2017-1-155 medical ethical committe
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group clomiphene citrate 50mg BID 5 days CC given for 5 days to control patient to assess its effectiveness to control bleeding 100
Control Group control gprou placebo BID 5 DAYS one tablet of placebo given twice daily for 5 days in patients bleeding on top of DMPA 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
any woman at any age, any weight, any parity who are DMPA user for any period who complaining of irregular uterine bleeding. any general causes of vaginal bleeding as known bleeding tendency abnormal coagulation profile anticoagulant drugs users or hepatic patients 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/12/2016 medical ethical comittee
Ethics Committee Address
Street address City Postal code Country
minia university minia 61111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome stopping of bleeding one month
Secondary Outcome endometrial thickness , continuity of bleeding stoppage any side effects 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
minia maternity university hospital minia university minia 61111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
department of obstetric and gynecology minia university minia 61111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor department of obstetric and gynecology, maternity hospital minia university minia 61111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
department of obstetric and gynecology, maternity hospital minia university minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hany hassan kamel hanyhassan19733@yahoo.com 00201001204427 minia university
City Postal code Country Position/Affiliation
minia 61111 Egypt assistaant professor of obstetric and gynecology, faculty of medicine, minia university , egypt
Role Name Email Phone Street address
Public Enquiries ahmed samir sanad asasanad@hotmail.com 002/01000222994 minia university
City Postal code Country Position/Affiliation
minia 61111 Egypt assistant professor of obstetrics and gynecology faculty of medicine minia university egypt
Role Name Email Phone Street address
Scientific Enquiries reham refaat elkhateeb rehamelkhateeb78@yahoo.com 002/01011966648 minia university
City Postal code Country Position/Affiliation
minia 61111 Egypt lecturer of obstetrics and gynecology faculty of medicine minia university egypt
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information