Health EducationPhase 1NCT04262024
Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.
A Phase 1 study testing cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education and cabergoline 1.5-2 mg/week).orally daily for 1 month without health education in people with Health Education, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Health Education
- What is being tested?
- cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education and cabergoline 1.5-2 mg/week).orally daily for 1 month without health education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 1 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pathologic hyperprolactinemia due to any cause.
- Non-pregnant.
- Not lactating.
Who cannot join
- Physiologic hyperprolactinemia.
- Women who don't consent for follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read more
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
Read the 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.
- Conditions
- Health Education
- Being tested
- 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
- Keywords
- health education, prolactin, hyperprolactinemia, resistant
- Medical subject headings
- Health Education, Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabergoline 1.5-2 mg/week).orally daily for 1 month plus health educationDrug
Also called cabergoline 1.5-2 mg/week+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)
cabergoline 1.5-2 mg/week).orally daily for 1 month without health educationDrug
Also called cabergoline 1.5-2 mg/week
Women with hyperprolactiemia scheduled for cabergoline 1.5-2 mg/week).for one month will not be offered health education (group B)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Women with hyperprolactinemia are scheduled for cabergoline therapy cabergoline 1.5-2 mg/week. for one month plus health education. Receives: 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. Receives: Drug: cabergoline 1.5-2 mg/week).orally daily for 1 month without health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Feb 2020
- Primary completion5 Jan 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective study ( randomized controlled trial)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Atef Darwish, Woman's Health University Hospital, Egypt
- Investigators
- Atef M Darwish, Prof, Principal investigator, Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262024
- Sponsor's protocol ID
- Clinical trial
- Status last verified
- May 2023
- First submitted
- 1 Feb 2020
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04262024
- Acronym / sponsor ID
- Clinical trial
- Conditions
- Health Education
- Keywords
- health education, prolactin, hyperprolactinemia, resistant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective study ( randomized controlled trial)
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: cabergoline 1.5-2 mg/week).orally daily for 1 month plus health educationWomen with hyperprolactinemia are scheduled for cabergoline therapy cabergoline 1.5-2 mg/week. for one month plus health education. |
| Group B | Active comparator | Drug: cabergoline 1.5-2 mg/week).orally daily for 1 month without health educationWomen with hyperprolactinemia are scheduled for cabergoline therapy 1.5-2 mg/week. for one month without health education. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pathologic hyperprolactinemia due to any cause.
- Non-pregnant.
- Not lactating.
Key exclusion criteria (2 listed)
- Physiologic hyperprolactinemia.
- Women who don't consent for follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cabergoline 1.5-2 mg/week).orally daily for 1 month plus health educationAlso: cabergoline 1.5-2 mg/week+health educationWomen 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) | Drug | Group A |
| cabergoline 1.5-2 mg/week).orally daily for 1 month without health educationAlso: cabergoline 1.5-2 mg/weekWomen with hyperprolactiemia scheduled for cabergoline 1.5-2 mg/week).for one month will not be offered health education (group B) | Drug | Group B |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
Related trials for Health Education
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Mobile Game-Based Versus Classic First Aid Education in Adolescents: Randomized Controlled Trial
First Aid, Health Education in Schoolchildren
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atef M Darwish, Prof principal investigator
Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education and cabergoline 1.5-2 mg/week).orally daily for 1 month without health education in people with Health Education, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.