Clinical Guidance for Proper Treatment of Unexplained Resistant

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04262024
Study type	Interventional
Source	Woman's Health University Hospital, Egypt
Contact
Status	Completed
Phase	Phase 1
Start date	February 1, 2020
Completion date	May 1, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms