A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy

NCT04982692 | Completed Phase 3

• 1 other identifier: INT-ZK-2021
• Study Type: interventional
• Target: 417
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postmenopausal Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  week 12

Secondary Outcomes (5)

• Change in vaginal dryness and vaginal irritation/itching severity score at day 85 (12 weeks).

  week 12

• Change in Female Sexual Function Index at Day 85 (12 weeks).

  week 12

• Effects on DHEA in blood

  week 12

• Changes in the gynecological vaginal examination.

  week 12

• Adverse event.

  week 6，week 12

Study Arms (2)

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.

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.

Drug: Placebo ovules

Interventions

intravaginal prasterone DRUG

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.

Also known as: Intrarosa

Intravaginal prasterone

Placebo ovules DRUG

Placebo ovules once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.

Placebo ovules

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• long Sui

  No. 419, Fangxie Road, Huangpu District, Shanghai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 29, 2021
• Study Start: September 13, 2021
• Primary Completion: January 30, 2023
• Study Completion: May 8, 2023
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)