Your session is about to expire
← Back to Search
Hormone Therapy
Estradiol Inserts for Painful Intercourse
Phase 3
Recruiting
Research Sponsored by Teva Pharmaceuticals USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom (dyspareunia) of VVA by the patient at screening visit. (i.e., a VVA Symptom Self-Assessment Questionnaire score of 2 or 3) (Appendix B).
Females aged 40-75 years inclusive who are postmenopausal, with at least:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 days
Awards & highlights
Study Summary
This trial tested the effect of a drug on patients with clinical results measured at multiple locations.
Who is the study for?
This trial is for postmenopausal women aged 40-75 experiencing painful intercourse due to vaginal atrophy. Participants must have a stable blood pressure, normal PAP smear and mammogram results, be sexually active, and not have used certain hormonal treatments recently. Women with a history of certain cancers, significant heart or liver disease, drug abuse within the last year, or those who are pregnant cannot participate.Check my eligibility
What is being tested?
The study tests if Estradiol Vaginal Inserts (4mcg) are as effective as IMVEXXY® in treating dyspareunia caused by vulvar and vaginal atrophy. It's randomized and double-blind; participants will receive either the test medication or placebo without knowing which one they're getting to compare outcomes fairly.See study design
What are the potential side effects?
Potential side effects may include typical estrogen-related reactions such as nausea, headaches, breast tenderness, spotting or bleeding from the vagina. There could also be local irritation where the product is applied. Serious but rare risks involve blood clots or stroke.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience moderate to severe pain during sex, which is my main concern.
Select...
I am a woman aged 40-75 and have gone through menopause.
Select...
I experience moderate to severe pain during sex, which is my main concern.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Most Bothersome Symptom
Responder
Secondary outcome measures
Treatment Success in Most bothersome symptom
Side effects data
From 2018 Phase 4 trial • 64 Patients • NCT0225517518%
Breast Tenderness
15%
Cramps
15%
Itchiness at patch site
12%
Headaches
9%
Nausea
6%
Acne
6%
Lower Back Pain
6%
Hot Flashes
6%
Menstrual Bleeding
6%
Bloating
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perimenopausal Women, Depressed
Perimenopausal Women, Non-depressed
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Estradiol vaginal inserts, 4 mcgExperimental Treatment1 Intervention
Estradiol vaginal inserts, 4 mcg. Insert vaginally once daily for 14 days.
Group II: IMVEXXY® (estradiol vaginal inserts) 4 mcgActive Control1 Intervention
IMVEXXY® (estradiol vaginal inserts) 4 mcg. Insert vaginally once for 14 days.
Group III: Placebo vaginal insertsPlacebo Group1 Intervention
Placebo vaginal inserts. Insert vaginally once for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
2008
Completed Phase 4
~3960
Find a Location
Who is running the clinical trial?
Teva Pharmaceuticals USALead Sponsor
230 Previous Clinical Trials
187,150 Total Patients Enrolled
C DiasStudy DirectorTeva Pharmaceuticals USA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable or unwilling to give informed consent.I do not have liver or kidney problems.I have a history of ongoing or frequent pelvic pain.I have been sexually active in the last month.My recent PAP smear results do not prevent me from using vaginal estradiol.I do not have any current vaginal infections.I have a skin condition affecting my vulva or vagina.I have used vaginal hormonal products like rings, creams, or gels in the last 4 weeks.You are a heavy smoker (more than 15 cigarettes per day) or use e-cigarettes.I had both ovaries removed at least 6 weeks ago.I plan to be sexually active and agree to have sex at least once between study days 10-13.My last mammogram and breast exam were normal.I have controlled thyroid issues or diabetes but no other hormone problems.I have a history of blood clots.I have had a stroke or a mini-stroke in the past.Vaginal pH > 5.0.\nI am a woman under 55 and have not had a period for at least 6 months, or I've had my ovaries removed.I have used hormone therapy with estrogen or progestin in the last 6 months.You have had problems with alcohol or drugs within the past year.I have been diagnosed with interstitial cystitis.I have had recent surgery or radiation therapy in the vaginal or cervical areas.My uterus is intact with an endometrial thickness of 4mm or more.I have used hormone patches within the last 4 weeks.I have had a cancer that grows with estrogen, like endometrial cancer.I have a history of blood clotting disorders.I have unusual growths in my vulva or vagina not caused by thinning tissues.I have not had a vaginal herpes outbreak in the last 40 days.I have been diagnosed with endometrial hyperplasia in the past or currently.I have or might have had breast cancer.I have painful genital warts or sores.I have not had sex or used a vaginal douche in the last 24 hours.I understand and can follow the study's requirements.I am premenopausal, perimenopausal, pregnant, breastfeeding, or planning to become pregnant.My lab results do not show any issues that would make estradiol unsafe for me.I have unclear or suspicious breast exam or mammogram results.I have not taken hormone-related drugs like estrogen or SERMs in the last 8 weeks.I am a woman under 55, had a hysterectomy before menopause, and my FSH level is over 40.I am not taking any medication that affects how my body processes drugs.I am not taking any strong CYP3A4 inhibitors like certain antibiotics, antifungals, HIV drugs, or consuming grapefruit juice.I have had a heart attack or heart disease.You are allergic or have a strong reaction to estrogen.I had a normal mammogram and breast exam within the last 9 months.I have been sexually active in the last month.I am a woman aged 40-75 and have gone through menopause.I haven't used any treatments for vaginal dryness or irritation in the last 2 weeks.You have experienced sexual abuse in the past that could affect how you perceive or report pain during sexual activity.You have a history of serious health problems like liver or heart issues, diabetes, high cholesterol, kidney problems, or certain medical conditions that could put you at risk or affect the study results.I have used intrauterine progestin therapy within the last 8 weeks.You are currently using marijuana.I experience moderate to severe pain during sex, which is my main concern.I experience moderate to severe pain during sex, which is my main concern.I plan to be sexually active and agree to have sex at least once between study days 10-13.I have had unexplained vaginal bleeding or am at high risk for endometrial cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Estradiol vaginal inserts, 4 mcg
- Group 2: Placebo vaginal inserts
- Group 3: IMVEXXY® (estradiol vaginal inserts) 4 mcg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are Estradiol vaginal inserts, 4 mcg FDA compliant?
"Estradiol vaginal inserts, 4 mcg received a score of 3 for safety. This is because it is a phase 3 trial, meaning that there is both efficacy data and multiple rounds of safety data available."
Answered by AI
Are patients currently being sought for this experiment?
"No, the trial isn't recruiting patients right now. The last time the listing was updated was on November 14th, 2022 and it initially was posted on November 8th, 2022. Having said that, there are other medical trials looking for participants as we speak."
Answered by AI
Can people of ages 18 and up participate in this experiment?
"This particular trial is only for patients aged 40-75. In contrast, there are 45 other trials that study treatments for those under 18 and 145 different clinical trials focused on individuals over the age of 65."
Answered by AI
For which patient population is this research applicable?
"This clinical trial is seeking 1026 individuals aged 40 to 75 that suffer from dyspareunia. Eligible candidates must meet the following requirements: Signed, IRB approved informed consent that meets all criteria of current FDA and local regulations., 12 months of spontaneous amenorrhea (women <55 year of age with history of hysterectomy without bilateral oophorectomy prior to natural menopause must have Serum follicle-stimulating hormone (FSH) level > 40 mIU/mL); or 6 months of spontaneous amenorrhea with FSH levels >40mIU/mL; or At least"
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Texas
What site did they apply to?
Site 10122
Site 10120
Site 10109
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
just curious on why i have certain symptoms during intercourse.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Site 10120: < 24 hours
- Site 10112: < 48 hours
Average response time
- < 2 Days
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger