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.: PACTR202105631565416 Date of Approval: 17/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A RANDOMISED CONTROLLED COMPARISON OF VAGINAL AND ORAL BROMOCRIPTINE IN THE MANAGEMENT OF HYPERPROLACTINEMIA AMONG WOMEN ATTENDING INFERTILITY CLINIC IN ABUTH.
Official scientific title A RANDOMISED CONTROLLED COMPARISON OF VAGINAL AND ORAL BROMOCRIPTINE IN THE MANAGEMENT OF HYPERPROLACTINEMIA AMONG WOMEN ATTENDING INFERTILITY CLINIC IN ABUTH.
Brief summary describing the background and objectives of the trial Background: Hyperprolactinemia is a common disorder affecting about one-third of infertile females. Treatment aims to normalize prolactin levels, reduce symptoms and restore fertility. The most common treatment approach is with the dopamine receptor agonists; bromo¬criptine and cabergoline. Cabergoline is preferred but it is expensive and bromocriptine which is affordable is often associated with side effects warranting its discontinuation in many. This poses a dilemma in developing countries where the cost of health care is often prohibitive with the user fee payment method. Aim: To compare the effectiveness and side-effects of oral bromocriptine with vaginal administration of bromocriptine in the treatment hyperprolactinemia among women attending infertility clinic in ABUTH. Research Methodology: This is a randomized, controlled trial, recruiting 64 infertile women with hyperprolactinemia from the Gynecology outpatient clinic of ABUTH. Informed consent will be obtained. Bromocriptine will be administered at a dose of 2.5mg daily via the oral or vaginal route in either of two randomly selected groups. Follow-up will be done over a period of six weeks with review of medication, side-effects and serum prolactin levels using Enzyme Linked Fluorescence Assay (ELFA) technique at fortnightly intervals. The primary outcome measures will be percentage and unit drop in serum prolactin levels in each group and proportion of women who experience side effects during the course of the study while the secondary outcome measures will be the proportion of women who experience relief of symptoms and discontinuation rate at the end of the study. Results: Findings will be reported based on the 2010 CONSORT statement and checklist for reporting randomized controlled trials. Relevant tables and diagrams will be used to improve understanding. Drug efficacy will be compared based on the percentage reduction in serum prolactin level, percentage of patients who experienced adverse effects and symptom control at the end of the study. Conclusion: The study seeks to find a cost effective, readily available and safe plan in the management of hyperprolactinemia in our patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2020
Actual trial start date 01/11/2020
Anticipated date of last follow up 01/08/2021
Actual Last follow-up date 01/09/2021
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 64
Recruitment status Recruiting
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Oral Bromocriptine 2.5mg daily per os 6 weeks 2.5mg of bromocriptine to be given daily per os 32 Active-Treatment of Control Group
Experimental Group Vaginal bromocriptine 2.5mg bromocriptine daily per vaginum 6 weeks 2.5mg of bromocriptine will be given per vaginam daily 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This will include consenting and well-motivated infertile women with laboratory evidence of hyperprolactinemia who are ready to comply with study requirements (clinic visits, repeated blood collections, vaginal drug administrations and timely use of medications). Women with space occupying lesions or other complications requiring urgent intervention, those with active genital tract infections or cancers, renal or hepatic insufficiency, those already on treatment at the time of the study, nonconsenting women and those with allergies to any component of the drugs will be excluded from the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 12/02/2021 Health Research ethics committee
Ethics Committee Address
Street address City Postal code Country
Shika Zaria 810211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Percentage fall in serum prolactin levels during treatment in both arms of the study. 2. Unit drop in prolactin levels in both study groups. 3. Proportion of women who experience side-effects in both arms of the study. fortnightly
Secondary Outcome 1. Proportion of women in both arms who achieve symptom relief following treatment. 2. Drug discontinuation rate in both groups. fortnightly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Shika Zaria 810211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Irshad Asma Ahmadu Bello University Teaching Hospital Zaria 810211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Irshad Asma Shika Zaria 810211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Sana Irshad 1728 Juniper Drive Bowling Green Ohio United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asma Irshad irshadasma9@gmail.com +2348134720840 Shika
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Aliyu Sokomba drsokomba@gmail.com +2348035935832 Shika
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Adebiyi Adesiyun biyi.adesiyun@yahoo.com +2348037861630 Shika
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria ABUTH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IDP that underlie result in a publication Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2025 Registered researchers
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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