Clinical trial NCT02497547 (phase 2, status: completed)
Conditions: atrophy
ICD codes: H21.29, H31.23, H47.20, H47.22, N50.0, N64.2, N90.5
Drugs: oxytocin, placebo
SMILES: [H][C@@]1(C[C@@](C)(OC)[C@@H](O)[C@H](C)O1)O[C@H]1[C@H](C)[C@@H](O[C@]2([H])O[C@H](C)C[C@@H]([C@H]2O)N(C)C)[C@@](C)(C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@](C)(O)[C@@H](CC)OC(=O)[C@@H]1C)OC, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

        To participate in the study, a subject must:

          1. 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

          2. 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

          3. Have ≤ 5% superficial cells in vaginal smear cytology at screening

          4. Have a vaginal pH > 5.0 at screening

          5. Have a level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH)
             > 40 milli International Units (mIU)/ml at screening

          6. 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

          7. Have a Body Mass Index (BMI) ≤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 35 days prior to the
             initial dose of study medication

          9. Have endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in
             women with an intact uterus

         10. 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:

          1. Be currently hospitalized

          2. 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

          3. Have had or have any known or suspected tumor 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 at 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 screening procedures

         10. Have used any type of vaginal lubricants and moisturizers within 24 hours prior to
             screening procedures

         11. Have used estrogen alone or estrogen/progestin for any of the time periods specified
             in the protocol

         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 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

         14. Have contraindication to any planned study procedure