Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.
Primary Purpose
Health Education
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education
cabergoline 1.5-2 mg/week).orally daily for 1 month without health education
Sponsored by
About this trial
This is an interventional health services research trial for Health Education focused on measuring health education, prolactin, hyperprolactinemia, resistant
Eligibility Criteria
Inclusion criteria:
- Pathologic hyperprolactinemia due to any cause.
- Non-pregnant.
- Not lactating.
Exclusion criteria:
- Physiologic hyperprolactinemia.
- Women who don't consent for follow up.
Sites / Locations
- Woman's Health University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Women with hyperprolactinemia are scheduled for cabergoline therapy cabergoline 1.5-2 mg/week. for one month plus health education.
Women with hyperprolactinemia are scheduled for cabergoline therapy 1.5-2 mg/week. for one month without health education.
Outcomes
Primary Outcome Measures
Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia
response of hyperprolactinemic women to carbergoline o.5 mg for one month with or without health education by a nurse to achieve normoprolactinemia.
Secondary Outcome Measures
Full Information
NCT ID
NCT04262024
First Posted
February 1, 2020
Last Updated
May 23, 2023
Sponsor
Woman's Health University Hospital, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04262024
Brief Title
Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.
Official Title
Clinical Guidance to Increase Women's Awareness of Some Contributing Factors to Help Proper Treatment of Unexplained Resistant Hyperprolactinemia Not Responding to Therapeutic Dopamine Agonists (DA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Many women despite being well-treated in proper dose, with proper drug and for proper duration, may not respond to different forms of prolactin normalizing drugs.
This will lead to extension of the treatment duration up to months or even years.
Doctors usually increase the dose of the drug with high possibility of side effects and even complications. Some doctors change drug group to another without any significant improvement of hyperprolactinemia. hyperprolactinemia can indicate a deeper issue, about 10 percent of the population has hyperprolactinemia. Life style, feeding habits and sexual behaviors are usually not included in the management protocols of hyperprolactinemia.
Aim of the study:
This study will be aimed to:
test the impact of clinical guidance to increase women's awareness of some contributing factors to help proper treatment of unexplained resistant hyperprolactinemia not responding to therapeutic DA (cabergoline 1.5-2 mg/week).
Hypothesis of the study:
H1- Health education for women under drugs of hyperprolactinemia is effective to reduce the level of prolactin.
H0- Health education for women under drugs of hyperprolactinemia is not effective in reducing the level of prolactin
Detailed Description
Subjects and methods:
All women diagnosed to have hyperprolactinemia as diagnosed by one laboratory (lab of the Woman's Health University Hospital).
Research Design:
Prospective study (randomized controlled trial) .
Setting:
This study will be conducted at the outpatient clinic of the Woman's Health University Hospital, Assiut University.
Sample size: convenience sample started from February 2020 to January 2023 or reached 120 cases, 60 in each arm.
Statistical analysis
Data entry and statistical analysis will be done using the statistical package for social science program (SPSS. version 22). Qualitative variables will be presented as number and percentage. Quantitative variables will be presented as mean +SD. Comparison between qualitative variables will be done by using chi-square. Comparison between quantitative variables will be done by using student t-test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Education
Keywords
health education, prolactin, hyperprolactinemia, resistant
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Prospective study ( randomized controlled trial)
Masking
Participant
Masking Description
Hyperprolactinemic women receiving cabergoline therapy will be divided into 2 groups: with health education and without health education.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Women with hyperprolactinemia are scheduled for cabergoline therapy cabergoline 1.5-2 mg/week. for one month plus health education.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Women with hyperprolactinemia are scheduled for cabergoline therapy 1.5-2 mg/week. for one month without health education.
Intervention Type
Drug
Intervention Name(s)
cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education
Other Intervention Name(s)
cabergoline 1.5-2 mg/week+health education
Intervention Description
Women with hyperprolactiemia scheduled for cabergoline therapy 1.5-2 mg/week). for one month will be offered health education to help minimize prolactin level(group A)
Intervention Type
Drug
Intervention Name(s)
cabergoline 1.5-2 mg/week).orally daily for 1 month without health education
Other Intervention Name(s)
cabergoline 1.5-2 mg/week
Intervention Description
Women with hyperprolactiemia scheduled for cabergoline 1.5-2 mg/week).for one month will not be offered health education (group B)
Primary Outcome Measure Information:
Title
Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia
Description
response of hyperprolactinemic women to carbergoline o.5 mg for one month with or without health education by a nurse to achieve normoprolactinemia.
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Pathologic hyperprolactinemia due to any cause.
Non-pregnant.
Not lactating.
Exclusion criteria:
Physiologic hyperprolactinemia.
Women who don't consent for follow up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atef M Darwish, Prof
Organizational Affiliation
Prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woman's Health University Hospital
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.
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