Vaginal Atrophy MedDRA version: 19.0 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy System Organ Class: 100000004872
Conditions
Interventions
Product Name: Vagitocin 400 IU
Pharmaceutical Form: Vaginal gel
INN or Proposed INN: Oxytocin
CAS Number: 50-56-6
Current Sponsor code: Oxytocin
Other descriptive name: Oxytocin
Concentration unit: IU
Sponsors
PEPTONIC medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients have to meet all of the following criteria to be eligible to enter the study: 1. 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. 2. 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. 3. Have = 5% superficial cells in vaginal smear cytology at screening. 4. Have a vaginal pH > 5.0 at screening. 6. 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 [yes/no]) that has been identified by the subject as being the most bothersome to her. 7. Have a body mass index =32 kg/m2. 8. Be judged by the Principal Investigator or Sub-investigator as being in otherwise good health based on a pre-study medical evaluation performed within 21 days prior to the initial dose of study medication. The medical evaluation findings must include: a. A normal or clinically non-significant finding at physical examination. b. A normal or clinically non-significant heart rate. c. A mean sitting systolic blood pressure =150 mm Hg and diastolic blood pressure =90 mm Hg at screening. Hypertensive subjects controlled with stable medications, who have a blood pressure =150 mm Hg (systolic) and = 90 (diastolic) mm Hg are suitable for inclusion. d. A normal or clinically non-significant finding at gynaecological examination. e. A normal mammography that has been performed within 36 months prior to initial dose of study medication. A normal mammogram is defined as a mammogram in which no masses or other findings are diagnosed which are suspected of being malignant. The investigational site has to make all possible efforts to obtain a copy of the official mammography report, or an oral statement from the mammography clinic, for the subject's study file. f. A normal or clinically non-significant finding at clinical breast examination. An acceptable breast examination is defined as an examination in which no masses or other findings are identified which are suspected of being malignant. g. An acceptable Papanicolaou (“Pap”) smear for subjects with an intact uterus and cervix (can be performed within previous 6 months prior to initial dose of study medication). An acceptable cervical smear is defined as a smear in which no dysplastic or malignant cells are identified. h. Laboratory values within normal limits or with non-significant deviations from normal values. 9. Have an endometrial thickness of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will not be permitted to enter the study: 1. Currently hospitalized. 2. 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. 3. Have had or have any known or suspected tumour disease that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator. 4. Have a history of endometrial hyperplasia or uterine/endometrial, breast or ovarian cancer. 5. Have a history of undiagnosed vaginal bleeding. 6. Have an ongoing urogenital infection in spite of treatment at the randomization visit. 7. Any contraindication to oxytocin therapy and allergy to the use of oxytocin and any components of the investigational drugs. 8. Have a history of drug and/or alcohol abuse within one year of start of study. 9. Have used any prescription or over the counter (OTC) medications including phytoestrogens, herbal medicinal products or hormonal intra-uterine device with known estrogenic effects within 12 weeks prior to the screening visit. 10. Have used any type of vaginal lubricants and moisturizers within 24 hours prior to the screening Visit. 11. 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. 12. 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. 13. 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. 14. Have contraindication to any planned study procedure. 15. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Vagitocin in reducing the severity of the most bothersome symptom of vulvovaginal atrophy (VVA) associated with menopause after 12 weeks of treatment. ;Secondary Objective: Secondary Objective: • To evaluate safety and tolerability of 400 IU of Vagitocin. Exploratory Objectives: • To evaluate the efficacy, safety and tolerability of Vagitocin administered by two different applicators. • To evaluate plasma levels of oxytocin after administration of 400 IU of Vagitocin by two different applicators. ;Primary end point(s): Change from baseline to Week 12 in severity of the VVA symptom (vulvar and 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. ;Timepoint(s) of evaluation of this end point: 12 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints Efficacy: • Change from baseline to Week 4 in severity of the VVA symptom (vulvar and 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. • Change from baseline to Week 4 and 12 in % superficial cells (increase is positive). • Change from baseline to Week 4 and 12 in vaginal pH (decrease is positive). • Change from baseline to Week 4 and 12 o % parabasal cells (decrease is positive). o maturation value (increase is positive). • Change from baseline to Weeks 4 and 12 in severity of VVA symptoms (vulvar and vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity [yes/no]). • Change from baseline to Week 12 in Quality of Life (QoL) evaluation parameters. • Change from baseline to Week 12 in body weight. Safety: • Change from baseline over time of clinical safety data: adverse events (AEs), vital signs, physical examination findings, gynaecological examination findings, breast examination findings, laboratory tests, transvaginal ultrasound and pap smear. Exploratory Endpoints: • Plasma concentrations of oxytocin administered by two different applicators. • Efficacy of oxytocin administered via the laminate tube (the same efficacy endpoints as for the main study). • Safety of oxytocin administered via the laminate tube (the same safety endpoints as for the main study). ;Timepoint(s) of evaluation of this end point: 4 and 12 weeks from baseline | — |
Countries
Sweden
Contacts
Public ContactLinn Skärberg
PCG Clinical Services
Outcome results
None listed