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NCT Number: NCT04262024

Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.

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

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Key information

Conditions

Health Education Adherence Interventions Behavior Brain Diseases Central Nervous System Diseases Endocrine System Diseases Health Behavior Hyperpituitarism Hyperprolactinemia Hypothalamic Diseases Medication Adherence Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Pituitary Diseases Treatment Adherence and Compliance

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Woman's Health University Hospital

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologic hyperprolactinemia due to any cause.
  • Non-pregnant.
  • Not lactating.

Exclusion criteria

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

Treatment and study plan

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

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)

Other names: cabergoline 1.5-2 mg/week+health education

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

Drug

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

Other names: cabergoline 1.5-2 mg/week

Primary outcomes

  1. Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia

    Time frame: 1 month

    response of hyperprolactinemic women to carbergoline o.5 mg for one month with or without health education by a nurse to achieve normoprolactinemia.

Sponsors and collaborators

Lead sponsor

Woman's Health University Hospital, Egypt

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2020
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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