- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02755038
Scalp Hair Estradiol and Progesterone Level Determination in Women (Proof of Concept Study)
Scalp Hair Estradiol and Progesterone Level Determination in Pre-menopausal and Post-menopausal Women (Proof of Concept Study)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Haifa, Israel, 31048
- Rekruttering
- Samer Khoury
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Ta kontakt med:
- Samer Khoury, MD
- Telefonnummer: 97248359100
- E-post: samer.khoury@b-zion.org.il
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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concentration of hair scalp progesterone
Tidsramme: 3 months
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concentration of hair scalp progesterone (nmol\L)
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3 months
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concentration of hair scalp estrogen
Tidsramme: 3 months
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concentration of hair scalp estrogen (pmol\L)
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3 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: samer khoury, Bnai Zion Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- BNZ160015CTIL
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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