HealthyNCT02755038
Scalp Hair Estradiol and Progesterone Level Determination in Women (Proof of Concept Study)
An observational study of Healthy, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesis is that we can determine estrogen and progesterone levels in the hair by using the immune method and we can show a significant difference in the levels of these hormones in both groups of women: pre- and postmenopausal women. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Mar 2017
- Phase
- Observational
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: One group will include 20 women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year.
Who may be able to join
- women under 40 with regular cycles
- Women over the age of 60 in menopause for at least 5 years
Who cannot join
- pregnant women
- oral contraceptive treatment in the last year
- hormonal replacement therapy in the last year
- 6 month after delivery
- infertile women
- irregular menstruation
Show all 13Show fewer
- women with progesterone secretion intrauterine device in the last year
- BMI- Body Mass Index- below 25 or above 35
- Polycystic Ovarian Syndrome
- steriodal treatment including inhalers and ointments.
- status post Removal of the ovaries or uterus
- Breast or uterine cancer in the past.
- any pituitary or adrenal disease
Trial locations and contacts
1 site in 1 country.
samer khoury, MD contact
Einav Kadour contact
Israel1 site, 1 recruiting
- Recruiting
Samer Khoury
Haifa, 31048
Samer Khoury, MD, 97248359100, samer.khoury@b-zion.org.il
About this study
Official title: Scalp Hair Estradiol and Progesterone Level Determination in Pre-menopausal and Post-menopausal Women (Proof of Concept Study)
The investigators hypothesis is that we can determine estrogen and progesterone levels in the hair by using the immune method and we can show a significant difference in the levels of these hormones in both groups of women: pre- and postmenopausal women. If indeed it would then be possible in future to carry out research that can find a relationship between the levels of these hormones and various diseases
Read the detailed description
One group will include 20 women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year.
From all of the participants the investigators will collect hair samples at the crown back of the head (hair will be cut as close as possible to the scalp), the samples will be measured quantitatively about 100 hairs at a length of 2-3 cm. In order to grind the hair samples we will use a mini-Bead beater machine. milled hairs will be incubated overnight in a solution of 1 ml methanol 50, in constant gentle muddling. Afterwards, ethanol will disperse through a stream of nitrogen. The remainder of the suspension will be dissolved at 200 microliter buffer PBS (Phosphate-Buffered Saline) (pH 8.0) and the concentration of estrogen and progesterone will be measured by using the immune method which is available in the endocrine laboratory in Bnai Zion medical center. At the end of the study the investigators will cary out a statistical comparison of progesterone and estrogen levels between the two groups.
- Conditions
- Healthy
- Keywords
- postmenopausal women, scalp hair, estrogen, progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| premenopausal and postmenopausal women | One group will include 20 premenopausal women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 postmenopausal women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of hair scalp progesterone
concentration of hair scalp progesterone (nmol\L)
Measured: 3 months
concentration of hair scalp estrogen
concentration of hair scalp estrogen (pmol\L)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, samer.khoury, Bnai Zion Medical Center
- Investigators
- samer khoury, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755038
- Sponsor's protocol ID
- BNZ160015CTIL
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalp Hair Estradiol and Progesterone Level Determination in Pre-menopausal and Post-menopausal Women (Proof of Concept Study)
- ClinicalTrials.gov ID
- NCT02755038
- Acronym / sponsor ID
- BNZ160015CTIL
- Conditions
- Healthy
- Keywords
- postmenopausal women, scalp hair, estrogen, progesterone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Mar 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- 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.
The investigators hypothesis is that we can determine estrogen and progesterone levels in the hair by using the immune method and we can show a significant difference in the levels of these hormones in both groups of women: pre- and postmenopausal women. If indeed it would then be possible in future to carry out research that can find a relationship between the levels of these hormones and various diseases
Detailed description
One group will include 20 women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year.
From all of the participants the investigators will collect hair samples at the crown back of the head (hair will be cut as close as possible to the scalp), the samples will be measured quantitatively about 100 hairs at a length of 2-3 cm. In order to grind the hair samples we will use a mini-Bead beater machine. milled hairs will be incubated overnight in a solution of 1 ml methanol 50, in constant gentle muddling. Afterwards, ethanol will disperse through a stream of nitrogen. The remainder of the suspension will be dissolved at 200 microliter buffer PBS (Phosphate-Buffered Saline) (pH 8.0) and the concentration of estrogen and progesterone will be measured by using the immune method which is available in the endocrine laboratory in Bnai Zion medical center. At the end of the study the investigators will cary out a statistical comparison of progesterone and estrogen levels between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premenopausal and postmenopausal women | – | –One group will include 20 premenopausal women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 postmenopausal women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One group will include 20 women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year.
Key inclusion criteria (2 listed)
- women under 40 with regular cycles
- Women over the age of 60 in menopause for at least 5 years
Key exclusion criteria (13 listed)
- pregnant women
- oral contraceptive treatment in the last year
- hormonal replacement therapy in the last year
- 6 month after delivery
- infertile women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concentration of hair scalp progesterone
Time frame: 3 months
concentration of hair scalp progesterone (nmol\L)
concentration of hair scalp estrogen
Time frame: 3 months
concentration of hair scalp estrogen (pmol\L)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
samer khoury, MD contact
Einav Kadour contact
samer khoury principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Bnai Zion Medical Center at 1 site in Israel.
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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Apr 2016. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact samer khoury, MD (samer.khoury@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of hair scalp progesterone (time frame: 3 months). The study lists 2 primary outcomes in all. 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 28 Apr 2016.