MenopausePhase 3NCT02224313
Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
A Phase 3 study testing oral estradiol 1.0 mg and oral progesterone 100 mg in people with Menopause, run by Intira Sriprasert at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- oral estradiol 1.0 mg and oral progesterone 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Premenopausal and Postmenopausal women:
- 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.
- 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).
- No oral hormone therapy for 8 weeks and transdermal or vaginal hormone therapy for 4 week prior to the study.
- Willing to use oral hormone therapy during the study period (postmenopausal women only).
- Willing to abstain from using products (other than study medication) that contain estrogen, progestin, or progesterone throughout study participation.
Show all 9Show fewer
- Have general good health.
- Willing to refrain from sexual intercourse for 48 hours before vaginal sample collection.
- Willing to abstain from use of vaginal product 7 days before vaginal sample collection.
Who cannot join
- To participate in the study, a subject must NOT
- Be allergic to estrogen or progesterone products
- 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
- Have a known contraindication for oral hormone therapy or allergy to use of estradiol and/or progesterone
- 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
Show all 17Show fewer
- Have used tamoxifen, raloxifene or other selective estrogen receptor modulators (SERMs) therapy within 8 weeks prior to screening
- Have used an intrauterine device (IUD) within 8 weeks prior to screening
- Have used vaginal products (pessary, tampon, tablets, douching) within 7 days prior to screening
- Have evidence of cervical, vaginal, or vulvar intraepithelial neoplasia or cancer
- Have a past or current history breast cancer, endometrial cancer or endometrial hyperplasia, hypertriglyceridemia or venous thromboembolism
- Be an immuno-compromised patient including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents
- Have a history of or current evidence of thromboembolism
- Have evidence of uncontrolled Hypertension Blood pressure >140/100 mmHg
- Have confirmed Diabetes Mellitus
- Currently smoking
- For sexually active premenopausal women, should be protected against pregnancy by sterilization, condom use, abstinence, or same sex relationship
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Menopause
- Being tested
- oral estradiol 1.0 mg, oral progesterone 100 mg
- Keywords
- vaginal cytokine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral estradiol 1.0 mgDrug
Also called Estrace
one tablet of oral estradiol 1.0 mg once a day for 28 days
oral progesterone 100 mgDrug
Also called Prometrium
one tablet of oral progesterone 100 mg once a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1.Premenopausal women | No intervention | No treatment |
| 2.Postmenopausal women with hormones | Experimental | Oral hormone therapy will be given to women in this group. Daily dose of oral "estradiol" 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral "estradiol" 1 mg and "progesterone" 100 mg for 14 days will be given during the following 14 days. Receives: Drug: oral estradiol 1.0 mg; Drug: oral progesterone 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Cytokines at Baseline
Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.
Measured: At baseline visit
Secondary outcomes (1)
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.
Measured: At 14 days and 28 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startDec 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intira Sriprasert
- Sponsor type
- University, hospital or other
- Collaborators
- TherapeuticsMD
- Responsible party
- Sponsor-investigator, Intira Sriprasert, Eastern Virginia Medical School
- Investigators
- David F Archer, MD, Study director, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224313
- Sponsor's protocol ID
- CRC-VgCy
- Status last verified
- Mar 2020
- First submitted
- 30 Jul 2014
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02224313
- Acronym / sponsor ID
- CRC-VgCy
- Conditions
- Menopause
- Keywords
- vaginal cytokine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Intira SriprasertUniversity, hospital or other
- Collaborators
- TherapeuticsMD
- Study start
- Dec 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Premenopausal women | No intervention | –No treatment |
| 2.Postmenopausal women with hormones | Experimental | Drug: oral estradiol 1.0 mg, Drug: oral progesterone 100 mgOral hormone therapy will be given to women in this group. Daily dose of oral "estradiol" 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral "estradiol" 1 mg and "progesterone" 100 mg for 14 days will be given during the following 14 days. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Premenopausal and Postmenopausal women:
Key exclusion criteria (17 listed)
- To participate in the study, a subject must NOT
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral estradiol 1.0 mgAlso: Estraceone tablet of oral estradiol 1.0 mg once a day for 28 days | Drug | 2.Postmenopausal women with hormones |
| oral progesterone 100 mgAlso: Prometriumone tablet of oral progesterone 100 mg once a day for 14 days | Drug | 2.Postmenopausal women with hormones |
Primary outcome
Vaginal Cytokines at Baseline
Time frame: At baseline visit
Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.
1 secondary outcome
Vaginal Cytokines During Follow-up
Time frame: At 14 days and 28 days follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The manuscript is not yet on Pubmed but it is in press in Climacteric journal.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David F Archer, MD study director
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral estradiol 1.0 mg and oral progesterone 100 mg in people with Menopause, run by Intira Sriprasert at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Cytokines at Baseline (time frame: At baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.