Clinical trial
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)
Name
Clinical trial
Description
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
Trial arms
Trial start
2020-02-01
Estimated PCD
2023-01-05
Trial end
2023-05-01
Status
Completed
Phase
Early phase I
Treatment
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)
Arms:
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
Women with hyperprolactiemia scheduled for cabergoline 1.5-2 mg/week).for one month will not be offered health education (group B)
Arms:
Group B
Other names:
cabergoline 1.5-2 mg/week
Size
120
Primary endpoint
Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia
1 month
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective study ( randomized controlled trial)', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Hyperprolactinemic women receiving cabergoline therapy will be divided into 2 groups: with health education and without health education.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2023-05-25
1 organization
1 product
1 indication
Organization
Woman's Health University HospitalProduct
CabergolineIndication
Health Education