Postmenopausal Vulvovaginal AtrophyPhase 3NCT04982692
A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy
A Phase 3 study testing intravaginal prasterone in people with Postmenopausal Vulvovaginal Atrophy, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
This study is a phase III which includes two treatment phases. The phase 1 study is a multi-center, randomized, double-blind, placebo- controlled, parallel group that provide primary efficacy and safety data. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Postmenopausal Vulvovaginal Atrophy
- What is being tested?
- intravaginal prasterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2021to 8 May 2023
- 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
- Subject is between 40 and 80 years of age inclusive;
- Menopausal women (with or without hysterectomy) must also meet 1 of the following 3 conditions:
- A Non-hysterectomy, menopause ≥ 12 months; B. Menopause > 6 months and < 12 months or premenopausal hysterectomy, follicle stimulating hormone (FSH) > 40 IU/L; C ≥ 6 months since baseline assessment (Day 1) with or without hysterectomy.
- At screening and baseline (Day 1), the subject presented with moderate-severe dyspareunia (dyspareunia) as measured by the Vaginal Atrophy Symptom Questionnaire (VASQ) and self-rated as the most bothersome symptom.
- ≤ 5% superficial cells by vaginal smear at screening and baseline (Day 1).
- Vaginal pH > 5 at Screening and Baseline (Day 1).
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- Women (with or without a partner) who currently have sex or other sexual activity (masturbation, etc.) at least once a month, or who have sex or other sexual activity at least once a month in the past, with reduced sexual activity due to excessive pain or vaginal dryness.
- Normal physical examination of the breast and normal mammographic findings (BI-RADS grade 1 or 2) within 9 months prior to the baseline visit (Day 1).
- Normal cervical smear results (including inflammatory changes), regardless of hysterectomy (no abnormal cervical smear in the past 2 years if ASCUS is present, and human papillomavirus (HPV) test negative can be used) within 12 months before the baseline visit (Day 1).
- Voluntarily participate in this clinical trial and sign the informed consent form (ICF).
- -
Who cannot join
- Patients with a history of malignant tumor.
- Have active or history of thromboembolic disease (excluding thromboembolic events due to accidents, surgery, immobilization).
- Clinically significant endocrine metabolic disease (e.g., diabetes mellitus) not controlled with medication.
- Use of estrogen injections, estrogen implant sticks, progestogen injections, progestogen implants, androgens, anabolic steroids within 6 months of the screening visit.
- Use oral estrogen, oral progesterone, prasterone (DHEA) or intrauterine progesterone treatment, intravaginal hormonal drugs (ring, cream, gel or tablet), estrogen alone or estrogen/pregnancy within 8 weeks before the screening visit, hormone transdermal drug users.
- Confirmed depression with poor control under standard treatment or history of diagnosed psychiatric disorder.
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- Those who have participated in or plan to participate in other drug or device clinical trials during the study period within 1 month prior to the screening visit.
- Laboratory findings suggestive of glutamic-pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST) ≥ 2 times the upper limit of normal, or creatinine ≥ 1.5 times the upper limit of normal.
- Grade 2 and higher uterine prolapse (cervix reaching labia minora).
- Transvaginal ultrasound revealed a uterine fibroid ≥ 3 cm in diameter.
- Endometrial thickness ≥ 4 mm by transvaginal ultrasound, or other comprehensive assessment by the investigator with the possibility of endometrial hyperplasia, deterioration.
- Current endometrial polyps.
- Previous endometrial ablation.
- Patients with vulvar lichen sclerosus.
- Patients with unexplained vaginal bleeding.
- Patients who are known to be allergic to the study drug or its ingredients.
- Patients who have participated in other relevant clinical trials of the investigational drug (prasterone vaginal suppositories).
- History of past or present drug or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine).
- Subjects who are unable to perform the procedures required by the protocol, or any other subjects who are not suitable for this clinical study judged by the investigator.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase Ⅲ, Efficacy and Safety Study of INTRAROSA® (Prasterone) Vaginal Inserts on Postmenopausal Vulvovaginal Atrophy (VVA)
This study is a phase III which includes two treatment phases. The phase 1 study is a multi-center, randomized, double-blind, placebo- controlled, parallel group that provide primary efficacy and safety data.
The Phase 2 study is a single-arm, open-label conducted in a subset of subjects who completed the phase 1 study to provid additional long-term safety and efficacy.
Read the detailed description
The phase 1 study which includes the screening phase (up to 3 weeks) and treatment phase (12 weeks). After signing the informed consent, the inclusion and exclusion criteria will be confirmed preliminarily at screening visit and reconfirmed at Day 1 (baseline). At least 418 eligible subjects will be randomized in a 1:1 ratio to receive 6.5mg of intravaginal prasterone or placebo once-daily for 12 weeks.
The phase 2 study which includes the treatment phase (26 weeks). A total of 100 subjects who have completed Phase 1, not occur adverse event（AE） grade ≥3 or serious adverse event (SAE), or recover all AE grades ≤1, and voluntary to participate in Phase 2 study. After signing the ICF, the subject will receive 6.5mg of intravaginal for 26 weeks.
- Conditions
- Postmenopausal Vulvovaginal Atrophy
- Being tested
- intravaginal prasterone, Placebo ovules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravaginal prasteroneDrug
Also called Intrarosa
6.5 mg of Intravaginal prasterone once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.
Placebo ovulesDrug
Placebo ovules once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intravaginal prasterone | Experimental | 6.5 mg of Intravaginal prasterone once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks. Receives: Drug: intravaginal prasterone |
| Placebo ovules | Placebo comparator | Placebo ovules once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks. Receives: Drug: Placebo ovules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the dyspareunia (dyspareunia) severity score at Day 85.
Compared with Day 1, the changes in the dyspareunia (dyspareunia) severity score (by VASQ) at Day 85 (12 weeks) in the two groups of subjects.
Measured: week 12
The change in the vaginal pH at Day 85.
Compared with Day 1, the changes in the vaginal pH changes at Day 85 (12 weeks) in the two groups of subjects.
Measured: week 12
The change in the proportion of parabasal cells at Day 85.
Compared with Day 1, the changes in the proportion of parabasal cells at Day 85 (12 weeks) in the two groups of subjects.
Measured: week 12
The change in the proportion of superficial cells at Day 85.
Compared with Day 1, the changes in the proportion of superficial cells at Day 85 (12 weeks) in the two groups of subjects.
Measured: week 12
Secondary outcomes (5)
Change in vaginal dryness and vaginal irritation/itching severity score at day 85 (12 weeks).
Compared with the baseline period, at day 85 (12 weeks) in both groups: change in vaginal dryness and vaginal irritation/itching severity score by VASQ.
Measured: week 12
Change in Female Sexual Function Index at Day 85 (12 weeks).
Compared with the baseline period, the two groups at Day 85 (12 weeks): change in Female Sexual Function Index (FSFI questionnaire).
Measured: week 12
Effects on DHEA in blood
To test the concentrations of DHEA in blood.
Measured: week 12
Changes in the gynecological vaginal examination.
The changes of total severity score in the vaginal discharge, vaginal epithelial integrity, vaginal epithelial surface thickness, and vaginal color by gynecological vaginal examination.
Measured: week 12
Adverse event.
The proportion of adverse events.
Measured: week 6，week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start13 Sep 2021
- Primary completion30 Jan 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Vulvovaginal AtrophyStudies 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
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- long Sui, Principal investigator, No. 419, Fangxie Road, Huangpu District, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982692
- Sponsor's protocol ID
- INT-ZK-2021
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2021
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase Ⅲ, Efficacy and Safety Study of INTRAROSA® (Prasterone) Vaginal Inserts on Postmenopausal Vulvovaginal Atrophy (VVA)
- ClinicalTrials.gov ID
- NCT04982692
- Acronym / sponsor ID
- INT-ZK-2021
- Conditions
- Postmenopausal Vulvovaginal Atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 29 Jul 2021 (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.
This study is a phase III which includes two treatment phases. The phase 1 study is a multi-center, randomized, double-blind, placebo- controlled, parallel group that provide primary efficacy and safety data.
The Phase 2 study is a single-arm, open-label conducted in a subset of subjects who completed the phase 1 study to provid additional long-term safety and efficacy.
Detailed description
The phase 1 study which includes the screening phase (up to 3 weeks) and treatment phase (12 weeks). After signing the informed consent, the inclusion and exclusion criteria will be confirmed preliminarily at screening visit and reconfirmed at Day 1 (baseline). At least 418 eligible subjects will be randomized in a 1:1 ratio to receive 6.5mg of intravaginal prasterone or placebo once-daily for 12 weeks.
The phase 2 study which includes the treatment phase (26 weeks). A total of 100 subjects who have completed Phase 1, not occur adverse event（AE） grade ≥3 or serious adverse event (SAE), or recover all AE grades ≤1, and voluntary to participate in Phase 2 study. After signing the ICF, the subject will receive 6.5mg of intravaginal for 26 weeks.
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 |
|---|---|---|
| Intravaginal prasterone | Experimental | Drug: intravaginal prasterone6.5 mg of Intravaginal prasterone once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks. |
| Placebo ovules | Placebo comparator | Drug: Placebo ovulesPlacebo ovules once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is between 40 and 80 years of age inclusive;
- Menopausal women (with or without hysterectomy) must also meet 1 of the following 3 conditions:
- A Non-hysterectomy, menopause ≥ 12 months; B. Menopause > 6 months and < 12 months or premenopausal hysterectomy, follicle stimulating hormone (FSH) > 40 IU/L; C ≥ 6 months since baseline assessment (Day 1) with or without hysterectomy.
- At screening and baseline (Day 1), the subject presented with moderate-severe dyspareunia (dyspareunia) as measured by the Vaginal Atrophy Symptom Questionnaire (VASQ) and self-rated as the most bothersome symptom.
- ≤ 5% superficial cells by vaginal smear at screening and baseline (Day 1).
Key exclusion criteria (20 listed)
- Patients with a history of malignant tumor.
- Have active or history of thromboembolic disease (excluding thromboembolic events due to accidents, surgery, immobilization).
- Clinically significant endocrine metabolic disease (e.g., diabetes mellitus) not controlled with medication.
- Use of estrogen injections, estrogen implant sticks, progestogen injections, progestogen implants, androgens, anabolic steroids within 6 months of the screening visit.
- Use oral estrogen, oral progesterone, prasterone (DHEA) or intrauterine progesterone treatment, intravaginal hormonal drugs (ring, cream, gel or tablet), estrogen alone or estrogen/pregnancy within 8 weeks before the screening visit, hormone transdermal drug users.
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 |
|---|---|---|
| intravaginal prasteroneAlso: Intrarosa6.5 mg of Intravaginal prasterone once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks. | Drug | Intravaginal prasterone |
| Placebo ovulesPlacebo ovules once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks. | Drug | Placebo ovules |
Primary outcome
The change in the dyspareunia (dyspareunia) severity score at Day 85.
Time frame: week 12
Compared with Day 1, the changes in the dyspareunia (dyspareunia) severity score (by VASQ) at Day 85 (12 weeks) in the two groups of subjects.
The change in the vaginal pH at Day 85.
Time frame: week 12
Compared with Day 1, the changes in the vaginal pH changes at Day 85 (12 weeks) in the two groups of subjects.
The change in the proportion of parabasal cells at Day 85.
Time frame: week 12
Compared with Day 1, the changes in the proportion of parabasal cells at Day 85 (12 weeks) in the two groups of subjects.
The change in the proportion of superficial cells at Day 85.
Time frame: week 12
Compared with Day 1, the changes in the proportion of superficial cells at Day 85 (12 weeks) in the two groups of subjects.
5 secondary outcomes
Change in vaginal dryness and vaginal irritation/itching severity score at day 85 (12 weeks).
Time frame: week 12
Change in Female Sexual Function Index at Day 85 (12 weeks).
Time frame: week 12
Effects on DHEA in blood
Time frame: week 12
Changes in the gynecological vaginal examination.
Time frame: week 12
Adverse event.
Time frame: week 6，week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- 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.
long Sui principal investigator
No. 419, Fangxie Road, Huangpu District, Shanghai
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 intravaginal prasterone in people with Postmenopausal Vulvovaginal Atrophy, run by Lee's Pharmaceutical Limited at 1 site in China.
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 11 inclusion and 20 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 18 Oct 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in the dyspareunia (dyspareunia) severity score at Day 85. (time frame: week 12). The study lists 4 primary outcomes in all. 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 18 Oct 2024.