Clinical trial NCT04262024: Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health Education
Keywords: health education
prolactin
hyperprolactinemia
resistant
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective study ( randomized controlled trial)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health University Hospital
Study officials:
affiliation: Prof.
name: Atef M Darwish, Prof
role: PRINCIPAL_INVESTIGATOR
References: