Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.

NCT ID: NCT04262024

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-05-01

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.

Conditions

Health Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Group A

Women with hyperprolactinemia are scheduled for cabergoline therapy cabergoline 1.5-2 mg/week. for one month plus health education.

Group Type: ACTIVE_COMPARATOR

cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education

Intervention Type: DRUG

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)

Group B

Women with hyperprolactinemia are scheduled for cabergoline therapy 1.5-2 mg/week. for one month without health education.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Other Intervention Names

cabergoline 1.5-2 mg/week+health education; cabergoline 1.5-2 mg/week

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Professor Atef Darwish

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atef M Darwish, Prof

Role: PRINCIPAL_INVESTIGATOR

Prof.

Locations

Woman's Health University Hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Clinical trial

Identifier Type: -

Identifier Source: org_study_id