drugset / Trial / NCT04262024

Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.

NCT04262024

Phase 1 Completed 120 enrolled Woman's Health University Hospital, Egypt
RandomizedCrossoverSingle-blindHealth-services research

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

Timeline

Start
2020-02-01
Primary completion
2023-01-05
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cabergoline Small molecule 1.5 mg Oral
Comparator Cabergoline Small molecule 2 mg Oral

Indications

No indication recorded.