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

July 10, 2019 updated by: Reem Sabouni, Eastern Virginia Medical School
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Jones Institute for Reproductive Medicine
        • Contact:
          • Abby Peele
        • Contact:
          • Reem Sabouni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Micronized progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 4 weeks for each participant
The levels of serum estradiol and FSH in young women versus postmenopausal women.
Time Frame: up to 4 weeks for each participant
up to 4 weeks for each participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Virginia Medical School

Collaborators

Wichita State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 3, 2019

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (ACTUAL)

March 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-03-FB-0058-EVMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Follicle Stimulating Hormone Glycosylation

Clinical Trials on Estradiol Transdermal Product

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe