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Trial record 9 of 2075 for:    ESTRADIOL

Follicle Stimulating Hormone (FSH) Glycosylation in Women: Effect of Estradiol

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ClinicalTrials.gov Identifier: NCT03868202
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Wichita State University
Information provided by (Responsible Party):
Reem Sabouni, Eastern Virginia Medical School

Brief Summary:
This clinical trial is an investigational research study to determine the ratio of glycosylated FSH21/FSH24 in premenopausal women and postmenopausal women as well as determining if estradiol can increase this ratio in postmenopausal women.

Condition or disease Intervention/treatment Phase
Follicle Stimulating Hormone Glycosylation Urinary FSH21/FSH24 Ratio Estradiol Effect Drug: Estradiol Transdermal Product Phase 2

Detailed Description:

Follicle Stimulating Hormone (FSH), is secreted by the pituitary gland at the base of the brain, and is the primary stimulus for growth of the ovarian follicle that contains the egg. Glycosylation, or adding glucose, to FSH is critical for its bioactivity on stimulating the ovarian follicle. The FSH with less glycosylation (FSH21) has a higher affinity for the FSH receptor and activates more pathways than does fully-glycosylated FSH (FSH24). Previous studies showed pituitaries from young women contain a high ratio of FSH21/FSH24 while pituitaries from older and postmenopausal women have a lower ratio of FSH21/FSH24. The investigators hypothesize that the higher FSH21/FSH24 ratio found in young women is responsible for normal follicle growth.

This study is intended to provide the first determination of systemic changes in the ratio of FSH21/FSH24 and determine if estradiol increases the FSH21/FSH24 ratio in the first morning urine of women. To take part in this study, the participant must be willing to collect the first morning urine on particular mornings of the menstrual cycle and be available for blood draws on those mornings. Additionally for postmenopausal participants, the participant must be willing to use topical estrogen, EstroGel©, for 14 days and be willing to collect the first morning urine on particular mornings and again be available for blood draws on those mornings. For the postmenopausal participants with an intact uterus, the participants must be willing to take an oral progestin, micronized progesterone, for 12 days following the completion of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Follicle Stimulating Hormone (FSH) Glycosylation in Women: Effect of Estradiol
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
No Intervention: Premenopausal women
Participants will bring into clinic their first voided urine of the day on cycle days 9, 12 and 15 in a urinary collection kit that will be given. A urine dip stick will be performed on the samples. Each time they bring in a sample, they will have a serum blood draw for estradiol and FSH.
Active Comparator: Postmenopausal women
Participants will bring into clinic their first voided urine of the day on assigned days 1, 4 and 7 in a urinary collection kit that will be given. A urine dip stick will be performed on the samples. Each time they bring in a sample, they will have a serum blood draw for estradiol and FSH. The participants will then be started on EstroGel© for 14 days from day 7-21. During that time that they are on EstroGel©, the participants will bring into clinic their first voided urine of the day on assigned days 15, 18, and 21 in a urinary collection kit that will be given. A urine dip stick will be performed on the samples. Each time they bring in a sample, they will have a serum blood draw for estradiol and FSH. After the last urinary collection and blood draw, they will discontinue the EstroGel and be started on micronized progesterone if they have a uterus for 12 days.
Drug: Estradiol Transdermal Product
Hormone replacement therapy will be given to postmenopausal women for up to 1 month.
Other Name: Micronized progesterone




Primary Outcome Measures :
  1. The ratio of urinary FSH21/FSH24 and total FSH levels in urine of young women versus postmenopausal women. [ Time Frame: up to 4 weeks for each participant ]
  2. The levels of serum estradiol and FSH in young women versus postmenopausal women. [ Time Frame: up to 4 weeks for each participant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Premenopausal (Age 20-30):

  1. Age between 20 - 30 years old
  2. Not on oral, transdermal or vaginal hormonal contraception with last use greater than 2 months (non-hormonal IUD okay)
  3. At least 6 weeks after removal of subdermal contraceptive implant
  4. At least 9 months from the last hormonal contraceptive injection
  5. Regular menses with a 26-32 day interval
  6. Willingness to abstain from heterosexual intercourse or use barrier contraception during the study
  7. No serious medical illness
  8. Not on medication(s) effecting ovarian function
  9. Screening ultrasound on cycle day 12-14 with at least 1 follicle measuring >12mm.
  10. Normal pap smear within the last 3 years, if indicated (report needed)

Postmenopausal (Age 45-60):

  1. Age between 45-60 years old
  2. Last spontaneous menstrual period >1 year
  3. Vaginal pH > 5.0
  4. No contraindications to hormonal replacement therapy
  5. No major medical condition/current medication(s) that would impact use of hormone replacement therapy
  6. Never have been on hormone replacement therapy or last use greater than 6 months
  7. Mammogram within the last 1 year that is normal (report needed)
  8. Pap smear within the last 3-5 years that is normal (report needed)
  9. Willing to use hormone replacement therapy

Exclusion Criteria:

Premenopausal (Age 20-30):

  1. Uncorrected endocrinopathy affecting ovarian function (i.e.: Prolactinoma, thyroid disease)
  2. Medications affecting the hypothalamic-pituitary-ovarian axis.
  3. Screening ultrasound with no follicles measuring ≥11 mm
  4. History of pelvic surgery
  5. Current abnormal pap smear requiring intervention

Postmenopausal (Age 45-60):

  1. Last menstrual period <1 year
  2. Contraindication to hormone replacement therapy
  3. Use of exogenous hormone replacement therapy in the last 6 months
  4. Significant medical disease or current medication use that can impact estrogen metabolism
  5. Unwilling or unable to use transdermal estrogen and oral progestin.
  6. Allergy to transdermal estrogen and oral progestin.
  7. Unexplained vaginal bleeding within the last 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868202


Contacts
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Contact: Reem Sabouni, MD 757-446-7100 SabounR@evms.edu
Contact: David F Archer, MD 757-446-7444 ArcherDF@evms.edu

Locations
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United States, Virginia
Jones Institute for Reproductive Medicine Recruiting
Norfolk, Virginia, United States, 23507
Contact: Abby Peele         
Contact: Reem Sabouni, MD         
Sponsors and Collaborators
Eastern Virginia Medical School
Wichita State University

Publications:

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Responsible Party: Reem Sabouni, Principal Investigator, Fellow of Reproductive Endocrinology and Infertility, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT03868202     History of Changes
Other Study ID Numbers: 19-03-FB-0058-EVMS
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Hormones
Progesterone
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins