- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Haifa, Israel, 31048
- Rekrytering
- Samer Khoury
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Kontakt:
- Samer Khoury, MD
- Telefonnummer: 97248359100
- E-post: samer.khoury@b-zion.org.il
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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concentration of hair scalp progesterone
Tidsram: 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
Tidsram: 3 months
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concentration of hair scalp estrogen (pmol\L)
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3 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: samer khoury, Bnai Zion Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- BNZ160015CTIL
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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