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.: PACTR202105785593643 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 Controlle Study of Vaginal Bromocriptine and Oral Carbegoline in treating Hyperprolacrinemia among women Attending Infertility Clinic in Abuth
Official scientific title A Randomised Controlle Study of Vaginal Bromocriptine and Oral Carbegoline in treating Hyperprolacrinemia among women Attending Infertility Clinic in Abuth
Brief summary describing the background and objectives of the trial 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; bromocriptine 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 cabergoline with vaginal administration of bromocriptine in the treatment hyperprolactinemia among women attending infertility clinic. Research Methodology: This is a randomized, double-blinded, controlled trial, recruiting 60 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 vaginally daily or oral cabergoline 0.5mg twice weekly to participants 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 at fortnightly intervals. The primary outcome measures will be percentage drop in serum prolactin level in each group and proportion of women who experience side-effects at the end of the study. The secondary outcome measure will be patient satisfaction levels. 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 and safe plan 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 30/04/2021
Actual Last follow-up date 31/05/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Oral Cabergoline 0.5mg twice per week. i.e. 0.5mg on Mondays and Thursdays 6 weeks Oral cabergoline at a dose of 0.5mg was given once in twice a week. 30 Active-Treatment of Control Group
Experimental Group Vaginal bromocriptine Vaginal bromocriptine once daily every night 6 weeks Vaginal bromocriptine was administered once daily every night for the duration of the study 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Infertile women with hyperprolactinemia confirmed by measuring fasting serum prolactin levels. 2. Women who give informed consent to participate in the study. 3. Women who are motivated to comply with study requirements including clinic visits, repeated blood sampling, vaginal drug administration and timely use of medication. 1. Women with space occupying lesions or other complications requiring urgent intervention. 2. Women with active genital tract infections or cancers. 3. Renal or hepatic insufficiency. 4. Women who were already on treatment at the time of the study. 5. Women who were unable to provide informed consent. 6. Women with allergies to any component of the drugs. 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 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. Proportion of women who experience side-effects in both arms of the study. At two weeks interval for 6 weeks
Secondary Outcome 1. Proportion of women in both arms who achieve symptom relief following treatment. at the end of the study i.e. 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Giwa/Shika Zaria 810105 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 810105 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Adebiyi Gbadebo ADESIYUN Ahmadu Bello University Teaching Hospital Zaria 810211 Nigeria
Irshad Sana 1728, Juniper Drive Bowling Green Ohio United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asma Irshad Asma irshadasma@gmail.com 08134720840 Shika
City Postal code Country Position/Affiliation
Zaria 810105 Nigeria Senior resident Ahmadu Bello University Teaching Hospitl
Role Name Email Phone Street address
Public Enquiries Aliyu Sokomba drsokomba@gmail.com +2348035935832 Shika
City Postal code Country Position/Affiliation
Zaria 810105 Nigeria Senior Resident Ahmadu Bello University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Adesiyun Adebiyi biyi.adesiyun@yahoo.com +2348037861630 Shika
City Postal code Country Position/Affiliation
Zaria 810105 Nigeria Professor Ahmadu Bello University Teaching Hospital
Role Name Email Phone Street address
Principal Investigator Sana Irshad irshadsana72@gmail.com +14193789498 juniper drive ,apt 177
City Postal code Country Position/Affiliation
bowling green 43402 United States of America teaching assistant at bowling green state university
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 December 2025 Registered researchers
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 07/07/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/08/2022 Result - 11/08/2022 Result - 07/07/2022 Result - 07/07/2022 Result - 07/07/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information