Scalp Hair Estradiol and Progesterone Level Determination in Women (Proof of Concept Study)

NCT02755038 | Unknown

• 1 other identifier: BNZ160015CTIL
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Healthy

Keywords

postmenopausal women; scalp hair; estrogen; progesterone

Outcome Measures

Primary Outcomes (2)

• concentration of hair scalp progesterone

  concentration of hair scalp progesterone (nmol\\L)

  3 months

• concentration of hair scalp estrogen

  concentration of hair scalp estrogen (pmol\\L)

  3 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• women under 40 with regular cycles
• Women over the age of 60 in menopause for at least 5 years

You may not qualify if:

• pregnant women
• oral contraceptive treatment in the last year
• hormonal replacement therapy in the last year
• month after delivery
• infertile women
• irregular menstruation
• 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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Samer Khoury

Haifa, 31048, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Scalp Hair

Study Officials

• samer khoury

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

samer khoury, MD

CONTACT

samer.khoury@b-zion.org.il

Einav Kadour

CONTACT

einavkadour@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 28, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 28, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)