Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms

NCT04629885 | Completed Phase 2

• 2 other identifiers: OXYPEP2022016-000158-36
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 3

Brief Summary

A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts:

• The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in glass syringes, on postmenopausal women with vulvovaginal atrophy symptoms.
• The exploratory part of the study investigates the efficacy and safety of the IMP, intravaginally administered in a laminate tube, on postmenopausal women with vulvovaginal atrophy symptoms. A comparison of plasma levels of oxytocin when the IMP is administered by 2 different applicators will be investigated in a sub-group of patients. In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects receiving IMP and 80 subjects receiving placebo, in glass syringes. In the exploratory part of the study, 40 patients will be enrolled and randomized to 2 different groups; 30 subjects receiving IMP and 10 patients receiving placebo, in laminate tubes. The study is conducted at 3 sites in Sweden, and comprises 5 visits: screening visit (Visit 0), randomization visit (Visit 1; Day 0), treatment follow-up visit (Visit 2; Week 4), end of treatment visit (Visit 3; Week 12) and a telephone follow-up visit (Visit 4; Week 14). All patients self-administer the IMP once daily for 12 weeks.

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Change in severity of the most bothersome VVA symptom.

  Change in severity of the VVA symptom (vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity \[yes/no\]) that has been self-identified by the subject as being the most bothersome to her at baseline.

  Baseline and after 12 weeks of treatment.

Secondary Outcomes (13)

• Change in vaginal pH

  Baseline and 12 weeks of treatment.

• Change in % superficial cells

  Baseline and 12 weeks of treatment.

• Change in maturation value

  Baseline and 12 weeks of treatment.

• Change in summary score for the vulvovaginal atrophy symptoms.

  Baseline and 12 weeks of treatment.

• Change in severity of the most bothersome VVA symptom.

  Baseline and 4 weeks of treatment.

Other Outcomes (1)

• Plasma concentrations of oxytocin administered by two different applicators.

  30 minutes pre-dose, pre-dose (t=0), 15, 30, 60, 120 and 240 minutes post-dose.

Study Arms (2)

Oxytocin 400 IU

EXPERIMENTAL

1mL Oxytocin 400 IU vaginal gel once daily for 12 weeks

Drug: Oxytocin 400 IU vaginal gel

Placebo

PLACEBO COMPARATOR

1mL Placebo vaginal gel once daily for 12 weeks

Drug: Placebo

Interventions

Oxytocin 400 IU vaginal gel DRUG

Also known as: Vagitocin

Oxytocin 400 IU

Placebo DRUG

Matching placebo gel with identical appearance to the test product, used as reference treatment.

Also known as: Placebo (for Vagitocin)

Placebo

Eligibility Criteria

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

You may qualify if:

• Females aged 40-65 years at the time of screening, who are willing to participate in the study as indicated by signing the informed consent.
• Postmenopausal women with at least 24 months of spontaneous amenorrhea, or women who have had surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks ago.
• Have ≤ 5% superficial cells in vaginal smear cytology at screening.
• Have a vaginal pH \> 5.0 at screening.
• Have one moderate to severe vulvovaginal atrophy symptom (vulvar/vaginal irritation and itching, vaginal dryness, dysuria, dyspareunia or presence of vaginal bleeding associated with vaginal sexual activity) that has been identified by the subject as being the most bothersome to her.
• Have a body mass index (BMI) ≤32 kg/m2.
• Have an endometrial thickness of \<4 mm as determined by vaginal ultrasonography, in women with an intact uterus.
• Be willing to abstain from vaginal sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and at Visits 2 and 3.

You may not qualify if:

• Currently hospitalized.
• Have a history or ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
• Have had or have any known or suspected tumor disease that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
• Have a history of endometrial hyperplasia or uterine/endometrial, breast or ovarian cancer.
• Have a history of undiagnosed vaginal bleeding.
• Have an ongoing urogenital infection in spite of treatment at the randomization visit.
• Any contraindication to oxytocin therapy and allergy to the use of oxytocin and any components of the investigational drugs.
• Have a history of drug and/or alcohol abuse within one year of start of study.
• Have used any prescription or over-the-counter medications including phytoestrogens, herbal medicinal products or hormonal intra-uterine device with known estrogenic effects within 12 weeks prior to the screening visit.
• Have used any type of vaginal lubricants and moisturizers within 24 hours prior to the screening visit.
• Have used estrogen alone or estrogen/progestin for any of the following time periods: a) vaginal hormonal products (rings, creams, gels, vaginal suppositories) within 12 weeks prior to the screening visit, b) transdermal estrogen alone or estrogen/progestin products including percutaneous estrogen gels for at least 12 weeks prior to the screening visit, c) oral estrogen and/or progestin therapy within 12 weeks prior to the screening visit, d) intrauterine progestin therapy within 12 weeks prior to the screening visit, e) progestin implants and estrogen alone injectable drug therapy within 12 weeks prior to the screening visit, f) estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to the screening visit.
• Have any reason, which in the opinion of the Principal Investigator or Sub-Investigator would prevent the subject from safely participating in the study or complying with protocol requirements.
• Have participated in another clinical study within 90 days prior to screening, have received an investigational drug within three months prior to the initial dose of study medication, or be likely to participate in another clinical study or receive another investigational medication during the study.
• Have contraindication to any planned study procedure.
• Pregnancy.

Sponsors & Collaborators

• PepTonic Medical AB: lead

Study Sites (3)

Kvinnoforskningsenheten K59, Karolinska Universitetssjukhuset

Huddinge, 14186, Sweden

Location

Kvinnokliniken, Norrlands Universitetssjukhus

Umeå, 90185, Sweden

Location

Kvinnokliniken, Akademiska sjukhuset

Uppsala, 75185, Sweden

Location

MeSH Terms

Interventions

Oxytocin; Vaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Aino Fianu Jonasson, MD

  Kvinnoforskningsenheten K59, Karolinska Universitetssjukhuset, Huddinge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: May 8, 2017
• First Posted: November 16, 2020
• Study Start: May 3, 2016
• Primary Completion: May 3, 2017
• Study Completion: May 3, 2017
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)