Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.

Health Education Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262024
• Other study ID #: Clinical trial
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 1, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Education
• Hyperprolactinemia

Intervention

Drug:
• cabergoline 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)
• cabergoline 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)

Locations

Country	Name	City	State
Egypt	Woman's Health University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month