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

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborator: Wichita State University
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Follicle Stimulating Hormone; Hormones; Polyestradiol phosphate; Progesterone

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.