- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Haifa, 이스라엘, 31048
- 모병
- Samer Khoury
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연락하다:
- Samer Khoury, MD
- 전화번호: 97248359100
- 이메일: samer.khoury@b-zion.org.il
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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concentration of hair scalp progesterone
기간: 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
기간: 3 months
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concentration of hair scalp estrogen (pmol\L)
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: samer khoury, Bnai Zion Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .