Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.

NCT04262024 | Completed Phase 1 DMC

• 1 other identifier: Clinical trial
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Health Education

Keywords

health education; prolactin; hyperprolactinemia; resistant

Outcome Measures

Primary Outcomes (1)

• Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia

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

  1 month

Study Arms (2)

Group A

ACTIVE COMPARATOR

Women with hyperprolactinemia are scheduled for cabergoline therapy cabergoline 1.5-2 mg/week. for one month plus health education.

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

Group B

ACTIVE COMPARATOR

Women with hyperprolactinemia are scheduled for cabergoline therapy 1.5-2 mg/week. for one month without health education.

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

Interventions

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)

Also known as: cabergoline 1.5-2 mg/week+health education

Group A

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)

Also known as: cabergoline 1.5-2 mg/week

Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Health Education; Hyperprolactinemia

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Atef M Darwish, Prof

  Prof.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Hyperprolactinemic women receiving cabergoline therapy will be divided into 2 groups: with health education and without health education.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Model Details: Prospective study ( randomized controlled trial)

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 10, 2020
• Study Start: February 1, 2020
• Primary Completion: January 5, 2023
• Study Completion: May 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)