Recruiting
Phase 2

FSH with Estradiol

Sponsor:

Eastern Virginia Medical School

Code:

NCT03868202

Conditions

Follicle Stimulating Hormone Glycosylation

Urinary FSH21/FSH24 Ratio

Estradiol Effect

Eligibility Criteria

Sex: Female

Age: 20 - 55

Healthy Volunteers: Accepted

Interventions

Estradiol Transdermal Product

Study Details

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.

Conditions

Follicle Stimulating Hormone Glycosylation

Urinary FSH21/FSH24 Ratio

Estradiol Effect

Study ID

NCT03868202

Start date

Jul 3, 2019

Status verified date

Jul, 2019

Completion date

Jan, 2020

Anticipated

Primary completion date

Nov, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

Estradiol Transdermal Product

Hormone replacement therapy will be given to postmenopausal women for up to 1 month.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Reem Sabouni, MD

757-446-7100SabounR@evms.edu

David F Archer, MD

757-446-7444ArcherDF@evms.edu

Locations

Jones Institute for Reproductive Medicine

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Jul 12, 2019

Last verified

Jul, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2019-07-12.