Postmenopausal Atrophic Vaginitis
Conditions
Interventions
Stage 1/Group A:Promestriene Vaginal Soft Capsules Placebo + KAL-001 Live Bacteria Capsules
Stage 2 / Option 3 (selected as the final regimen from three options per interim analysis):KAL-001 live bacteria capsule
Stage 1/Group B:Promestriene vaginal capsule + KAL-001 live bacteria capsule placebo
Stage 2 / Option 1 (selected as the final regimen from three options per interim analysis):Promestriene vaginal capsule + KAL-001 live bacteria capsule placebo
Stage 1/Group D:Promestriene vaginal capsule placebo + KAL-001 live bacteria capsule placebo
Stage 1/Group C:Promestriene vaginal capsule + KAL-001 live bacteria capsule
Stage 2 / Option 1 (selected as the final regimen from three options per interim analysis):Promestriene vaginal capsule placebo + KAL-001 live bacteria capsule
Stage 2 / Option 2 (selected as the final regimen from three options per interim analysis):Promestriene vaginal capsule + KAL-001 live bacteria capsule
Stage 2 / Option 2 (selected as the final regimen from three options per interim analysis):Promestriene vaginal capsule + KAL-001 live bacteria capsule placebo
Stage 2 / Option 3 (selected as the final regimen from three options per interim analysis):KAL-001 live bacteria capsule placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form and be able to comply with the requirements of study procedures. 2. Female subjects with a history of sexual activity, aged >= 45 years and = 40 IU/L and estradiol (E2) <= 20 pg/mL. 4. At screening, the point-of-care vaginal pH value is greater than 5. 5. Within 3 months prior to screening, subjects shall have moderate or severe dyspareunia and moderate or severe vaginal dryness. The subject must have a stable sexual partner during the study and perform or attempt vaginal intercourse at least once every 3 weeks. Note: Dyspareunia: Moderate: Intercourse pain occurs most of the time with little sexual satisfaction; sexual intercourse is often interrupted due to pain. Severe: Constant dyspareunia, inability to gain sexual pleasure, occasional postcoital bleeding, and potential sexual abstinence secondary to dyspareunia. Vaginal dryness: Moderate: Vaginal dryness and discomfort present most of the time, without impairment of daily living. Severe: Persistent vaginal dryness and discomfort that interferes with daily living. (Refer to Appendix 1 for unified assessment grading.) 6. From the date of signing the informed consent form, subjects shall agree not to perform vaginal douching, use vaginal lubricants or moisturizers, or adopt other similar medicinal products or devices throughout the study period.
Exclusion criteria
Exclusion criteria: 1.Participants with genitourinary tract infections such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), bacterial vaginosis (BV) at screening, or those judged by the investigator to require antibiotic treatment. 2.Have received systemic or intravaginal antimicrobial agents or microecological preparations within 2 weeks prior to screening; or have received oral or local vaginal sex hormone drugs within 8 weeks prior to screening; or have used estrogen injections or implantable hormone therapy within 6 months prior to screening. 3.Have undergone surgical procedures or operative interventions involving the vulva, vagina, cervix or pelvic cavity within 10 weeks prior to screening. 4.At screening, subjects with unexplained abnormal vaginal bleeding or clinically significant gynecological diseases, including but not limited to vulvar dystrophy, vulvar eczema, uterine prolapse (Grade 2 or above, with cervical protrusion outside the vaginal orifice), endometrial hyperplasia (endometrial thickness = 4 mm), large uterine fibroids (diameter = 3 cm), ovarian tumors, etc. 5.At screening, subjects with a history of abnormal cervical cytology (excluding inflammatory changes), including but not limited to atypical squamous cells – cannot exclude high-grade squamous intraepithelial lesion (ASC-H), atypical squamous cells of undetermined significance (ASC-US), and other related abnormalities. 6.Subjects with known positive results for HPV-16 or HPV-18 on previous examinations at screening. 7.Subjects with a history of malignant tumors within 5 years prior to screening [excluding: a. carcinoma in situ without recurrence after radical resection; b. surgically cured basal cell carcinoma, squamous cell carcinoma and/or carcinoma in situ (Bowen’s disease) of the skin], or suspected breast cancer, or suspected sex hormone-dependent malignant tumors. 8.At screening, participants with uncontrolled clinically significant major diseases as judged by the investigator, including but not limited to diseases of the cardiovascular, respiratory, digestive, endocrine and metabolic, neuropsychiatric, hematological and immune systems. 9.At screening, the Breast Imaging Reporting and Data System (BI-RADS) grade from breast ultrasonography or mammography is greater than Grade 2. 10.Participants who are expected to require elective surgery within 3 months as assessed by the investigator at screening. 11.Have a history of severe allergy to the study drug or any of its excipients (immediate, life-threatening systemic hypersensitivity reactions). 12.Have participated in other interventional clinical trials within 3 months prior to screening, including trials for drugs, vaccines or medical devices, excluding observational studies of marketed drugs. 13.Any other conditions that may interfere with the assessment of the safety and efficacy of this trial, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in dyspareunia symptom score at the 12-week visit compared with baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in dyspareunia symptom score, vaginal dryness symptom score, and vaginal health index score (VHIS) at the 3-week, 6-week, and 12-week visits were compared with baseline respectively.;Assessment of AEs, SAEs, clinical laboratory tests, vital signs, physical and gynecological examinations, and other assessments; | — |
Countries
China
Contacts
Public ContactLan Zhu
Peking Union Medical College Hospital
Outcome results
None listed