MenopausePhase 3NCT03782480
Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
A Phase 3 study testing Intrarosa in people with Menopause and Genitourinary Syndrome of Menopause, run by Center for Vulvovaginal Disorders at 2 sites in United States.
Trial summary
Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Menopause, Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy
- What is being tested?
- Intrarosa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2019to 2 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 40 to 80 years.
- Women who have self-identified at screening pain at sexual activity as moderate to severe and most bothersome symptom of vulvovaginal atrophy (Refer to Vaginal Atrophy Symptoms Questionnaire (VASQ-MBS)).
- Women having ≤5% of superficial cells on vaginal smear at screening.
- Women having a vaginal pH above 5 at screening.
- Willing to participate in the study and sign an informed consent.
Who cannot join
- Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication.
- Use of estrogen injectable drug therapy and/or progestin implant within 6 months prior to screening visit.
- Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy within 8 weeks prior to screening visit.
- Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products within 8 weeks prior to screening visit.
- Previous treatment with androgens or anabolic steroids within 3 months prior to screening visit (see Appendix 15.1 - Concomitant medications).
- Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance.
Show all 12Show fewer
- The administration of any investigational drug within 30 days of screening visit.
- Clinically significant abnormal serum biochemistry, urinalysis or hematology (as per Investigator's assessment who should take into account the patient's pre-baseline conditions).
- Uterine palpable fibroids.
- Uterine prolapse (when the cervix reaches labia minora at gynecologic exam).
- Subjects who suffer from vulvar lichen sclerosus or any vulvar dermatological disorder that affects the vulvar vestibule or vagina.
- Chronic use of narcotics or alcoholism during the last 5 years.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
The Centers for Vulvovaginal Disorders
New York, New York, 10036
Leia Mitchell, MSc, 202-887-0568, leiam.cvvd@gmail.com
Andrew T Goldstein, MD
- Recruiting
The Centers for Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037
Leia Mitchell, MSc, 202-887-0568, leiam.cvvd@gmail.com
Andrew T Goldstein, MD
About this study
Official title: A Placebo-controlled Study Examining the Morphological/Biochemical Effects of Intrarosa on the Vulvar Vestibule and Vagina in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse.
Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse.
Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.
Read the detailed description
Tissues in the genitourinary system are both androgen- and estrogen-dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor are androgen-responsive. In addition, the minor vestibular glands and the major vestibular glands (Bartholin's and Skene's) are androgen-dependent, mucin-secreting glands. Deficiencies of both estrogens and androgens can occur both naturally during menopause or iatrogenically because of certain medications (e.g. Depo Lupron, spironolactone) or surgically (oophorectomy). Menopause-related deficiencies of these sex hormones lead to atrophic changes in the genitourinary system which have been termed genitourinary syndrome of menopause (GSM).
While erythema is a nonspecific finding in atrophic tissue, focal painful erythema in the androgen-dependent vestibule, particularly near the ostia of the Bartholin's glands (4:00 and 8:00 o'clock) and Skene's glands (1:00 and 11:00 o'clock) or lesser vestibular glands, is highly suggestive of GSM. Patients with GSM will frequently complain of penetrative dyspareunia and experience allodynia with the cotton swab palpation of the vulvar vestibule. During examination of the vulvar vestibule, the examiner might note general pallor with superimposed erythema. Physical exam can be improved by magnification (i.e. vulvoscopy).
Historically, GSM treatment involved both androgens and estrogens. However, in the absence of information about intracrinology, over the past few decades, estradiol-based therapies have been used exclusively. More recently, double-blind, placebo controlled clinical trials demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in postmenopausal women including moderate to severe dyspareunia. These trials have demonstrated improvement in both subjective measures (such as improvement in dyspareunia) as well as objective measurement of vaginal health (improved vaginal maturation index, decreased vaginal pH) but they have not attempted to demonstrate improvement in the health of the vulvar tissue.
- Conditions
- Menopause, Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy, Menopause Syndrome, Dyspareunia
- Being tested
- Intrarosa, Placebos
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntrarosaDrug
Also called prasterone, Dehydroepiandrosterone, DHEA
Prasterone intravaginal inserts
PlacebosDrug
Placebo intravaginal inserts
| Study group | Role | What they receive |
|---|---|---|
| Intrarosa | Active comparator | Daily intravaginal administration at bedtime of one insert containing 6.5mg (0.50%) prasterone for 26 weeks Receives: Drug: Intrarosa |
| Placebo | Placebo comparator | Daily intravaginal administration at bedtime of one insert containing placebo for 26 weeks Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in morphological content of vulvar and vaginal cells
Changes from baseline in density of androgen, estrogen and progesterone receptors. Unit of measure to be determined.
Measured: 2 years
Changes from baseline in morphological content of vulvar and vaginal cells
Changes from baseline in tissue steroid concentrations. Unit of measure to be determined.
Measured: 2 years
Changes from baseline in morphological content of vulvar and vaginal cells
Changes from baseline in blood steroid concentration. Unit of measure to be determined.
Measured: 2 years
Changes from baseline in protein content of vulvar and vaginal cells
Changes from baseline in mucin. Unit of measure to be determined.
Measured: 2 years
Changes from baseline in enzymatic content of vulvar and vaginal cells
Changes from baseline in enzymatic content (HSD17B5, HSD3B1, 5alphaRED2, aromatase, HDS17B1, sulfotransferase 2A1, sulfatase and UGT2B). All enzymes have the same unit of measure. Unit of measure to be determined.
Measured: 2 years
Changes from baseline in antigen content of vulvar and vaginal cells
Changes from baseline in PGP9.5. Unit of measure to be determined.
Measured: 2 years
Changes from baseline in antigen content of vulvar and vaginal cells
Changes from baseline in Ki-67 antigen. Unit of measure to be determined.
Measured: 2 years
Secondary outcomes (1)
Mean change from baseline in subject's scores on pain severity subscale VPAQ
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The pain severity subscale of the VPAQ consists of 3 pairs of verbal rating scale that test both pain intensity and pain affect. Each verbal rating scale is a 5-point scale with the following options: none=0, mild=1, moderate=2, severe=3, and worst possible=4. The calculated mean produces the overall score for the pain severity subscale ranging from 0-4 (4 is the worst score).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start2 Mar 2019 (estimated)
- Primary completion2 Jan 2021 (estimated)
- Study completion2 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Vulvovaginal Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- EndoCeutics Inc.
- Responsible party
- Principal investigator, Andrew T. Goldstein, MD, Center for Vulvovaginal Disorders
- Investigators
- Fernand Labrie, MD, Study director, EndoCeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782480
- Sponsor's protocol ID
- AGEC-10
- Status last verified
- Jan 2019
- First submitted
- 5 Dec 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Labrie F, Martel C, Pelletier G. Is vulvovaginal atrophy due to a lack of both estrogens and androgens? Menopause. 2017 Apr;24(4):452-461. doi: 10.1097/GME.0000000000000768.
PubMed 27875388Kingsberg S, Kellogg S, Krychman M. Treating dyspareunia caused by vaginal atrophy: a review of treatment options using vaginal estrogen therapy. Int J Womens Health. 2010 Aug 9;1:105-11. doi: 10.2147/ijwh.s4872.
PubMed 21072280Nappi RE, Palacios S. Impact of vulvovaginal atrophy on sexual health and quality of life at postmenopause. Climacteric. 2014 Feb;17(1):3-9. doi: 10.3109/13697137.2013.871696.
PubMed 24423885Labrie F. Intracrinology. Mol Cell Endocrinol. 1991 Jul;78(3):C113-8. doi: 10.1016/0303-7207(91)90116-a.
PubMed 1838082Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.
PubMed 25734980Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.
PubMed 26731686
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Study Examining the Morphological/Biochemical Effects of Intrarosa on the Vulvar Vestibule and Vagina in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT03782480
- Acronym / sponsor ID
- AGEC-10
- Conditions
- Menopause, Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy, Menopause Syndrome, Dyspareunia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Center for Vulvovaginal DisordersUniversity, hospital or other
- Collaborators
- EndoCeutics Inc.
- Study start
- 2 Mar 2019 (estimated)
- Primary completion
- 2 Jan 2021 (estimated)
- Study completion
- 2 Jan 2021 (estimated)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse.
Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse.
Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.
Detailed description
Tissues in the genitourinary system are both androgen- and estrogen-dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor are androgen-responsive. In addition, the minor vestibular glands and the major vestibular glands (Bartholin's and Skene's) are androgen-dependent, mucin-secreting glands. Deficiencies of both estrogens and androgens can occur both naturally during menopause or iatrogenically because of certain medications (e.g. Depo Lupron, spironolactone) or surgically (oophorectomy). Menopause-related deficiencies of these sex hormones lead to atrophic changes in the genitourinary system which have been termed genitourinary syndrome of menopause (GSM).
While erythema is a nonspecific finding in atrophic tissue, focal painful erythema in the androgen-dependent vestibule, particularly near the ostia of the Bartholin's glands (4:00 and 8:00 o'clock) and Skene's glands (1:00 and 11:00 o'clock) or lesser vestibular glands, is highly suggestive of GSM. Patients with GSM will frequently complain of penetrative dyspareunia and experience allodynia with the cotton swab palpation of the vulvar vestibule. During examination of the vulvar vestibule, the examiner might note general pallor with superimposed erythema. Physical exam can be improved by magnification (i.e. vulvoscopy).
Historically, GSM treatment involved both androgens and estrogens. However, in the absence of information about intracrinology, over the past few decades, estradiol-based therapies have been used exclusively. More recently, double-blind, placebo controlled clinical trials demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in postmenopausal women including moderate to severe dyspareunia. These trials have demonstrated improvement in both subjective measures (such as improvement in dyspareunia) as well as objective measurement of vaginal health (improved vaginal maturation index, decreased vaginal pH) but they have not attempted to demonstrate improvement in the health of the vulvar tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrarosa | Active comparator | Drug: IntrarosaDaily intravaginal administration at bedtime of one insert containing 6.5mg (0.50%) prasterone for 26 weeks |
| Placebo | Placebo comparator | Drug: PlacebosDaily intravaginal administration at bedtime of one insert containing placebo for 26 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women aged 40 to 80 years.
- Women who have self-identified at screening pain at sexual activity as moderate to severe and most bothersome symptom of vulvovaginal atrophy (Refer to Vaginal Atrophy Symptoms Questionnaire (VASQ-MBS)).
- Women having ≤5% of superficial cells on vaginal smear at screening.
- Women having a vaginal pH above 5 at screening.
- Willing to participate in the study and sign an informed consent.
Key exclusion criteria (12 listed)
- Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication.
- Use of estrogen injectable drug therapy and/or progestin implant within 6 months prior to screening visit.
- Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy within 8 weeks prior to screening visit.
- Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products within 8 weeks prior to screening visit.
- Previous treatment with androgens or anabolic steroids within 3 months prior to screening visit (see Appendix 15.1 - Concomitant medications).
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 |
|---|---|---|
| IntrarosaAlso: prasterone, Dehydroepiandrosterone, DHEAPrasterone intravaginal inserts | Drug | Intrarosa |
| PlacebosPlacebo intravaginal inserts | Drug | Placebo |
Primary outcome
Changes from baseline in morphological content of vulvar and vaginal cells
Time frame: 2 years
Changes from baseline in density of androgen, estrogen and progesterone receptors. Unit of measure to be determined.
Changes from baseline in morphological content of vulvar and vaginal cells
Time frame: 2 years
Changes from baseline in tissue steroid concentrations. Unit of measure to be determined.
Changes from baseline in morphological content of vulvar and vaginal cells
Time frame: 2 years
Changes from baseline in blood steroid concentration. Unit of measure to be determined.
Changes from baseline in protein content of vulvar and vaginal cells
Time frame: 2 years
Changes from baseline in mucin. Unit of measure to be determined.
Changes from baseline in enzymatic content of vulvar and vaginal cells
Time frame: 2 years
Changes from baseline in enzymatic content (HSD17B5, HSD3B1, 5alphaRED2, aromatase, HDS17B1, sulfotransferase 2A1, sulfatase and UGT2B). All enzymes have the same unit of measure. Unit of measure to be determined.
Changes from baseline in antigen content of vulvar and vaginal cells
Time frame: 2 years
Changes from baseline in PGP9.5. Unit of measure to be determined.
Changes from baseline in antigen content of vulvar and vaginal cells
Time frame: 2 years
Changes from baseline in Ki-67 antigen. Unit of measure to be determined.
1 secondary outcome
Mean change from baseline in subject's scores on pain severity subscale VPAQ
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Background: PubMed 27875388Labrie F, Martel C, Pelletier G. Is vulvovaginal atrophy due to a lack of both estrogens and androgens? Menopause. 2017 Apr;24(4):452-461. doi: 10.1097/GME.0000000000000768.
- Background: PubMed 21072280Kingsberg S, Kellogg S, Krychman M. Treating dyspareunia caused by vaginal atrophy: a review of treatment options using vaginal estrogen therapy. Int J Womens Health. 2010 Aug 9;1:105-11. doi: 10.2147/ijwh.s4872.
- Background: PubMed 24423885Nappi RE, Palacios S. Impact of vulvovaginal atrophy on sexual health and quality of life at postmenopause. Climacteric. 2014 Feb;17(1):3-9. doi: 10.3109/13697137.2013.871696.
- Background: PubMed 1838082Labrie F. Intracrinology. Mol Cell Endocrinol. 1991 Jul;78(3):C113-8. doi: 10.1016/0303-7207(91)90116-a.
- Background: PubMed 25734980Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.
- Background: PubMed 26731686Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.
- Individual participant dataSharing planned: No
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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.
Fernand Labrie, MD study director
EndoCeutics Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intrarosa in people with Menopause and Genitourinary Syndrome of Menopause, run by Center for Vulvovaginal Disorders at 2 sites 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leia Mitchell, MSc (2028870568, leiam.cvvd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in morphological content of vulvar and vaginal cells (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782480, which also lists 6 linked publications.
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 31 Jan 2019.