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Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.

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)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04262024
Enrollment
120
Registered
2020-02-10
Start date
2020-02-01
Completion date
2023-05-01
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Education

Keywords

health education, prolactin, hyperprolactinemia, resistant

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.

Interventions

DRUGcabergoline 1.5-2 mg/week).orally daily for 1 month plus 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)

DRUGcabergoline 1.5-2 mg/week).orally daily for 1 month without health education

Women with hyperprolactiemia scheduled for cabergoline 1.5-2 mg/week).for one month will not be offered health education (group B)

Sponsors

Woman's Health University Hospital, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

Hyperprolactinemic women receiving cabergoline therapy will be divided into 2 groups: with health education and without health education.

Intervention model description

Prospective study ( randomized controlled trial)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. Pathologic hyperprolactinemia due to any cause. 2. Non-pregnant. 3. Not lactating.

Exclusion criteria

1. Physiologic hyperprolactinemia. 2. Women who don't consent for follow up.

Design outcomes

Primary

MeasureTime frameDescription
Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia1 monthresponse of hyperprolactinemic women to carbergoline o.5 mg for one month with or without health education by a nurse to achieve normoprolactinemia.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026