Menopause
Conditions
Keywords
vaginal cytokine
Brief summary
The purpose of this study is to compare the vaginal health between premenopausal and postmenopausal women before and after using oral estradiol for 14 days then estradiol and progesterone for 14 days.
Detailed description
This research project recruits 10 healthy, premenopausal women (aged 20-40 years-old) with regular menstrual cycle with interval of 24-35 days and duration of 2-7 days and 10 healthy postmenopausal women (aged 45-60 years-old) with an intact uterus and at least 12 months but not more than 36 months of spontaneous amenorrhea. Premenopausal women will not receive any study medication(s). Postmenopausal women will be assigned the intervention described below. • Oral estradiol 1.0 mg tablet for 14 days, then oral estradiol 1.0 mg tablet and progesterone 100 mg capsule for 14 days
Interventions
DRUGoral estradiol 1.0 mg
one tablet of oral estradiol 1.0 mg once a day for 28 days
DRUGoral progesterone 100 mg
one tablet of oral progesterone 100 mg once a day for 14 days
Sponsors
TherapeuticsMD
Intira Sriprasert
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Premenopausal and Postmenopausal women: 1. Female between the ages of 20 and 40 years (premenopausal arm), OR be a female between the ages of 45 and 65 years (postmenopausal arm) willing to participate in the study, as documented by signing the informed consent form. 2. Postmenopausal women with an intact uterus and at least 12 months of spontaneous amenorrhea (postmenopausal arm), OR be a premenopausal women with regular menstrual cycle with interval of 24-35 days and duration of 2-7 days (premenopausal arm). 3. No oral hormone therapy for 8 weeks and transdermal or vaginal hormone therapy for 4 week prior to the study. 4. Willing to use oral hormone therapy during the study period (postmenopausal women only). 5. Willing to abstain from using products (other than study medication) that contain estrogen, progestin, or progesterone throughout study participation. 6. Have general good health. 7. Willing to refrain from sexual intercourse for 48 hours before vaginal sample collection. 8. Willing to abstain from use of vaginal product 7 days before vaginal sample collection.
Exclusion criteria
* To participate in the study, a subject must NOT 1. Be allergic to estrogen or progesterone products 2. Have active genital infection or inflammation based on vaginal wet preparation, power of hydrogen (pH), whiff test and potassium hydroxide (KOH) preparation 2.1 Vulvovaginal candidiasis, trichomonas vaginitis or bacterial vaginitis 2.2 Sexually transmitted diseases including herpes simplex viral infection, gonorrhea and Chlamydia 3. Have a known contraindication for oral hormone therapy or allergy to use of estradiol and/or progesterone 4. Have used estrogen alone or estrogen/progestin for any of the following time periods: 4.1 Vaginal hormone products (ring, cream, gels) within 30 days prior to screening 4.2 Transdermal estrogen alone or estrogen/progestin products within 4 weeks prior to screening 4.3 Oral estrogen and/or progestin therapy within 8 weeks prior to screening 4.4 Progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months prior to screening 4.5 Estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to screening 4.6 Percutaneous estrogen lotions/gels within 4 weeks prior to screening 5. Have used tamoxifen, raloxifene or other selective estrogen receptor modulators (SERMs) therapy within 8 weeks prior to screening 6. Have used an intrauterine device (IUD) within 8 weeks prior to screening 7. Have used vaginal products (pessary, tampon, tablets, douching) within 7 days prior to screening 8. Have evidence of cervical, vaginal, or vulvar intraepithelial neoplasia or cancer 9. Have a past or current history breast cancer, endometrial cancer or endometrial hyperplasia, hypertriglyceridemia or venous thromboembolism 10. Be an immuno-compromised patient including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents 11. Have a history of or current evidence of thromboembolism 12. Have evidence of uncontrolled Hypertension Blood pressure \>140/100 mmHg 13. Have confirmed Diabetes Mellitus 14. Currently smoking 15. For sexually active premenopausal women, should be protected against pregnancy by sterilization, condom use, abstinence, or same sex relationship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Cytokines at Baseline | At baseline visit | Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Cytokines During Follow-up | At 14 days and 28 days follow-up | Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Premenopausal Women Premenopausal women at baseline | 10 |
| Postmenopausal Women Postmenopausal women at baseline | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Postmenopausal Women | Premenopausal Women | Total |
|---|---|---|---|
| Age, Continuous | 56.44 years STANDARD_DEVIATION 3.57 | 31.90 years STANDARD_DEVIATION 5.11 | 44.17 years STANDARD_DEVIATION 4.34 |
| Body mass index | 29.97 kg/m^2 STANDARD_DEVIATION 6.71 | 30.06 kg/m^2 STANDARD_DEVIATION 5.82 | 30.02 kg/m^2 STANDARD_DEVIATION 6.08 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 20 Participants |
| Sex/Gender, Customized Women | 10 Participants | 10 Participants | 20 Participants |
| Vaginal power of hydrogen (pH) | 6.33 pH STANDARD_DEVIATION 0.79 | 4.08 pH STANDARD_DEVIATION 0.17 | 5.21 pH STANDARD_DEVIATION 0.48 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Vaginal Cytokines at Baseline
Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.
Time frame: At baseline visit
Population: One postmenopausal women was excluded due to non-compliance of assigned intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premenopausal Women | Vaginal Cytokines at Baseline | IL-1β | 0.12 pg/ug protein | Standard Deviation 0.24 |
| Premenopausal Women | Vaginal Cytokines at Baseline | IL-8 | 2.73 pg/ug protein | Standard Deviation 3.67 |
| Postmenopausal Women | Vaginal Cytokines at Baseline | IL-1β | 0.04 pg/ug protein | Standard Deviation 0.04 |
| Postmenopausal Women | Vaginal Cytokines at Baseline | IL-8 | 3.19 pg/ug protein | Standard Deviation 3.38 |
Secondary
Vaginal Cytokines During Follow-up
Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women.
Time frame: At 14 days and 28 days follow-up
Population: Three premenopausal women were excluded due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premenopausal Women | Vaginal Cytokines During Follow-up | IL-1B at 28 days | 0.04 pg/ug protein | Standard Deviation 0.02 |
| Premenopausal Women | Vaginal Cytokines During Follow-up | IL-8 at 14 days | 0.92 pg/ug protein | Standard Deviation 1.4 |
| Premenopausal Women | Vaginal Cytokines During Follow-up | IL-1B at 14 days | 0.02 pg/ug protein | Standard Deviation 0.03 |
| Premenopausal Women | Vaginal Cytokines During Follow-up | IL-8 at 28 days | 0.69 pg/ug protein | Standard Deviation 0.33 |
| Postmenopausal Women | Vaginal Cytokines During Follow-up | IL-8 at 28 days | 1.69 pg/ug protein | Standard Deviation 1.7 |
| Postmenopausal Women | Vaginal Cytokines During Follow-up | IL-1B at 28 days | 0.03 pg/ug protein | Standard Deviation 0.04 |
| Postmenopausal Women | Vaginal Cytokines During Follow-up | IL-1B at 14 days | 0.04 pg/ug protein | Standard Deviation 0.07 |
| Postmenopausal Women | Vaginal Cytokines During Follow-up | IL-8 at 14 days | 1.34 pg/ug protein | Standard Deviation 0.96 |