Clinical trial NCT02755038: Scalp Hair Estradiol and Progesterone Level Determination in Women (Proof of Concept Study)
Official title: Scalp Hair Estradiol and Progesterone Level Determination in Pre-menopausal and Post-menopausal Women (Proof of Concept Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: postmenopausal women
scalp hair
estrogen
progesterone
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-04-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnant women
* oral contraceptive treatment in the last year
* hormonal replacement therapy in the last year
* 6 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

Primary outcomes:
measure: concentration of hair scalp progesterone
timeFrame: 3 months
measure: concentration of hair scalp estrogen
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Samer Khoury
Study officials:
affiliation: Bnai Zion Medical Center
name: samer khoury
role: PRINCIPAL_INVESTIGATOR
References: