A Phase 1 interventional study of cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education and cabergoline 1.5-2 mg/week).orally daily for 1 month without health education in Health Education, sponsored by Woman's Health University Hospital, Egypt. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Woman's Health University Hospital, Egypt · Phase 1, Interventional, and Health services research
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
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.
481 studies on the registry are indexed under Health Education; 110 are open to participants now.
This study's enrollment of 120 is close to the median of 132 across 450 interventional studies indexed under Health Education.
Browse Health Education studies →Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
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Exclusion criteria:
Women with hyperprolactinemia are scheduled for cabergoline therapy cabergoline 1.5-2 mg/week. for one month plus health education.
Drug: cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education
Women with hyperprolactinemia are scheduled for cabergoline therapy 1.5-2 mg/week. for one month without health education.
Drug: cabergoline 1.5-2 mg/week).orally daily for 1 month without health education
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)
Also known as: cabergoline 1.5-2 mg/week+health education
Women with hyperprolactiemia scheduled for cabergoline 1.5-2 mg/week).for one month will not be offered health education (group B)
Also known as: cabergoline 1.5-2 mg/week
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.
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2020 to primary completion in Jan 2023, 35 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Woman's Health University Hospital, Egypt