Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.
Condition: Health Education
MeSH terms: Hyperprolactinemia
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education; cabergoline 1.5-2 mg/week).orally daily for 1 month without health education
Intervention type(s): Drug; Drug
Intervention description(s): 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); Women with hyperprolactiemia scheduled for cabergoline 1.5-2 mg/week).for one month will not be offered health education (group B)
Other intervention name(s): cabergoline 1.5-2 mg/week+health education; cabergoline 1.5-2 mg/week
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective study ( randomized controlled trial)
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: health education; prolactin; hyperprolactinemia; resistant