An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy

Inclusion criteria

To participate in the study, a subject must:

• Be a female subject between the ages of 40 and 65 years at the time of randomization, who is willing to participate in the study as indicated by signing the informed consent
• Be a postmenopausal woman with at least 24 months of spontaneous amenorrhea or a woman, who has 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 a level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) > 40 milli International Units (mIU)/ml at screening
• Have one moderate to severe vaginal atrophy symptom (vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with 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
• Be judged by the Principal Investigator or Sub-investigator as being in otherwise good health based on a pre-study medical evaluation performed within 35 days prior to the initial dose of study medication
• Have endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in women with an intact uterus
• Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and at Visits 2 and 3

Exclusion criteria

To participate in the study, a subject must not:

• Be currently hospitalized
• Have a history of 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 at 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 (OTC) medications including phytoestrogens, herbal medicinal products or hormonal intra-uterine device with known estrogenic effects within 12 weeks prior to screening procedures
• Have used any type of vaginal lubricants and moisturizers within 24 hours prior to screening procedures
• Have used estrogen alone or estrogen/progestin for any of the time periods specified in the protocol
• 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 trial within 90 days prior to screening, have received an investigational drug within the three months prior to the initial dose of study medication, or be likely to participate in a clinical trial or receive another investigational medication during the study
• Have contraindication to any planned study procedure