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.: PACTR201704002167269 Date of Approval: 02/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: A randomized controlled trial
Official scientific title Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: A randomized controlled trial
Brief summary describing the background and objectives of the trial Introduction. In postmenopausal women, the vaginal epithelium becomes thinner, drier and less elastic due to lack of estrogen. Oxytocin is a hormone that increases mucosal blood flow and transport of nutrients as well as to stimulate the secretion of several growth factors and to induce mitosis in several types of cells. Design: Prospective randomized controlled study to test the effectiveness of topical oxytocin gel to improve vaginal atrophy in postmenopausal women. Patients &Methods. One hundred and forty qualified post-menopausal women presenting with vaginal atrophy were enrolled in the study and randomized into 2 groups each containing seventy patients the first received intravaginal oxytocin gel and the second received placebo gel for thirty days. Serum estrogen level, Visual, coloposcopic examination and vaginal biopsy were performed before and after treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied post-menopausal vaginal atrophy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2016
Actual trial start date 15/10/2016
Anticipated date of last follow up 01/04/2017
Actual Last follow-up date 08/04/2017
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 140
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Randomised Simple randomisation using a randomisation table created by a computer software Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oxytocin vaginal gel 1 ml. 1 mg of oxytoc once daily 30 days 1 mg of oxytocin gel mixed in carboxymethyl cellulose base(CMC). 70 Active-Treatment of Control Group
Control Group Methyl Cellulose (Placebo) 1 ml. 1 mg cellulose 30 days 1 mg of methyl cellulose 70 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Healthy postmenopausal women (at least two years after menopause) who were suffering from symptoms of vaginal atrophy (such as vaginal dryness, pain, itching, discomfort and bleeding during intercourse). ¿ Had not used any estrogen or other hormonal treatments (systemic or topical) during a four-week period prior to the trial. ¿ Any chronic illnesses. ¿ Allergy to oxytocin or cellulose. 42 Year(s) 60 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 13/04/2016 Ethical Committee of Air-Force specialized Hospital
Ethics Committee Address
Street address City Postal code Country
90 (El-Tessen) street- 5th settlement Cairo none Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Visual and colposcopic changes in vaginal mucosa Before treatment and after 30 days
Primary Outcome ¿ Histopathological evaluation of punch biopsy of the vaginal mucosa Before treatment and after 30 days
Primary Outcome Symptoms (Dyspareunia & soreness) Before treatment and after 30 days
Secondary Outcome ¿ Serum level of estradiol Before treatment and after 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Air-Force specialized Hospital Street 90 Cairo none Egypt
Al-Azhar University Downtown Cairo none Egypt
Al-Galaa Teaching Hospital Al-Galaa street Cairo none Egypt
October 6th University Central axis 6th October city none Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
none none none none
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Air-Force specialized Hospital 90 street Cairo none Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Asem Anwar Moussa 123 Moustafa Al-Nahass street- Medinat Nasr Cairo none Egypt
Haitham Torky Central axis 6th October city Not available Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asem A. Moussa dramoussa77@hotmail.com +201001414226 123 Moustafa Al-Nahass Street-Medinat Nasr
City Postal code Country Position/Affiliation
Cairo Egypt Professor of obstetrics & gynecology- Al-Azhar University
Role Name Email Phone Street address
Public Enquiries Asem A. Moussa dramoussa77@hotmail.com +201001414226 123 Moustafa Al-Nahass Street-Medinat Nasr
City Postal code Country Position/Affiliation
Cairo none Egypt Professor of obstetrics & gynecology- Al-Azhar University
Role Name Email Phone Street address
Scientific Enquiries Asem A. Moussa dramoussa77@hotmail.com +201001414226 123 Moustafa Al-Nahass Street-Medinat Nasr
City Postal code Country Position/Affiliation
Cairo none Egypt Professor of obstetrics & gynecology- Al-Azhar University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information