Vulvovaginal atrophy associated with menopause MedDRA version: 20.0 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Ovestin
Product Name: Ovestin
Pharmaceutical Form: Vaginal cream
INN or Proposed INN: ESTRIOL
CAS Number: 50-27-1
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Conce
Sponsors
Aspen Global Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Female participants aged = 45 to = 85 years. 2.Presence of at least one documented moderate or severe bothersome symptom of vulvovaginal atrophy. These symptoms include any of the following: •Pain during sexual intercourse (dyspareunia) •Vaginal dryness •Vaginal itching/irritation •Vaginal/vulvar soreness •Vulvar or vaginal bleeding (e.g. postcoital bleeding, fissures) •Vaginal discharge (leukorrhea or yellow and malodorous) •Pelvic pressure or a vaginal bulge •Urinary tract symptoms (e.g. urinary frequency, dysuria, urethral discomfort, hematuria) 3.Postmenopausal women; postmenopausal defined as: •12 months of spontaneous amenorrhea, or •6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. 4.Participants will comprise treatment-naïve postmenopausal women and treatment-experienced postmenopausal women who have discontinued hormone replacement therapy (either local or systemic). 5.Treatment-experienced participants should not be taking estrogen alone or estrogen/progestin containing drug products. The following washout periods are recommended before baseline assessments are made for participants previously on estrogen alone or estrogen/progestin containing products: •4 weeks or longer for prior vaginal hormonal products (rings, creams, gels) •4 weeks or longer for prior transdermal estrogen alone or estrogen/progestin products •8 weeks or longer for prior oral estrogen and/or progestin therapy •8 weeks or longer for prior intrauterine progestin therapy •3 months or longer for prior progestin implants and estrogen alone injectable drug therapy •6 months or longer for prior estrogen pellet therapy or progestin injectable drug therapy 6.Women must have documentation of a negative screening mammogram (obtained at screening or within 12 months prior to study enrollment) and normal clinical breast examination prior to enrollment. 7.Women must have documentation of a negative screening pap smear (obtained at screening or within six months prior to study enrollment). Negative defined as normal cytology or pap1 (normal cytomorphology) or pap2 (borderline dyskaryosis/ atypical squamous cells of undetermined significance (ASC-US)) and no suspected malignant abnormalities. 8.Participants must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial. 9.Women must have a documented negative urine pregnancy test unless they have had a bilateral oophorectomy and/or hysterectomy. 10.Stated willingness to comply with all study procedures and availability for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 505
Exclusion criteria
Exclusion criteria: 1.Clinical suspicion of endometrial hyperplasia, endometrial cancer or cervical cancer for participants who have a uterus. 2.Known, previous or suspected breast cancer. 3.Known, previous or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer). 4.Any malignancy unless free of disease for at least 5 years. 5.Undiagnosed uterine bleeding. 6.Known pelvic organ prolapse past the level of the hymen. 7.Evidence of vaginal infection on physical examination. 8.Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism). 9.Known thrombophilic disorders or conditions that may adversely affect coagulation, including: •Protein C, Protein S, or antithrombin III deficiency •Factor XIII mutation, familial dysfibrinogenemia, antiphospholipid syndrome, heparin-induced thrombocytopenia, paroxysmal nocturnal hemoglobinuria, sickle-cell disease, polycythemia vera, essential thrombocytosis, nephrotic syndrome •History of elevated levels of factor VIII, factor IX, factor XI, fibrinogen and thrombin-activatable fibrinolysis inhibitor, or decreased levels of tissue factor pathway inhibitor. 10.Acute or chronic liver disease. 11.A history of significant alcohol or drug abuse in the opinion of the investigator. 12.Use of any other investigational drug within 30 days or use of any of the prohibited medications, as outlined in section 7.5 of this protocol, leading up to the first dose of Ovestin. 13.Any physical, psychiatric or social condition which in the opinion of the investigator may: •put the participant at risk because of participation in the study •influence the results of the study •cause concern regarding the participant’s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Ovestin as Hormone Replacement Therapy (HRT) at 12 weeks after initiation of treatment of vulvar and vaginal atrophy symptoms in postmenopausal women;Secondary Objective: To evaluate the safety profile of Ovestin;Primary end point(s): •Mean change from baseline to Week 12 in at least one individual moderate to severe symptom that has been identified by the participant as being the most bothersome to her •Mean change from baseline to Week 12 in the percentage of superficial cells •Mean change from baseline to Week 12 in the percentage of parabasal cells •Mean change from baseline to Week 12 in vaginal pH ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Solicited and unsolicited adverse events •Change in serum estriol concentrations over time from baseline ;Timepoint(s) of evaluation of this end point: Throughout study duration | — |
Countries
Bulgaria, Poland, South Africa, Ukraine
Contacts
Public ContactClinical Operations Lead
Aspen Pharmacare Holdings LimitedCompany
Outcome results
None listed