Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy

Inclusion Criteria: * Healthy, pre-menopausal women; * Women aged 18 years and above; * Women who are undergoing an in-office procedure requiring uterine access along with a cervical dilatation of at least 5.5 mm; * Women participating in Part 1 of study: Women who have had at least one vaginal delivery of at least 24 weeks gestation; * Women with Pap smear results that do not require further evaluation for at least one year as assessed by the investigator. Note: 1) results must be from a Pap smear obtained within one year of screening; 2) if results are unavailable or not current, a Pap smear must be obtained and results reviewed prior to study inclusion; 3) if a Pap smear is to be performed at screening, subject must have a negative pregnancy test confirmed prior to the Pap smear collection; * Women of child bearing potential: 1) Must have a negative urine pregnancy test at screening and just prior to study drug insertion, if this takes place on a different day from the screening visit; 2) Agree to use a highly effective method of birth control (defined as a low failure rate of less than 1% per year) as follows: implants, injectables, combined oral contraceptives, sexual abstinence from the date of the subject's last menstruation until completion of the follow-up visit, vasectomised partner or barrier method (condom with spermicide). Women in a same sex relationship do not need to meet this criterion if they confirm that there is no possibility of pregnancy; * Women who agree to refrain from vaginal intercourse while the study drug is in place; * Women who agree to refrain from using any of the following from the day of study drug insertion until completion of the follow-up visit: feminine deodorant sprays/products, spermicides\*, douches, condoms\*, tampons, diaphragms or any other pharmaceutical or over the counter vaginal product. Barrier methods of contraception as indicated above (\*) may be resumed following the dilatation procedure; * Women who provide written informed consent. Exclusion Criteria: * Menopausal women; * Women with menstrual periods lasting \>10 days in duration; * Baseline internal cervical os ≥ 3 mm; * Women who have had prior endometrial ablation; * Women who are breastfeeding; * History or current diagnosis of glaucoma; * Women with clinically significant vaginal or cervical abnormality (e.g. symptoms of an infection) that would interfere with conducting study procedures prior to study drug insertion; * Women who are currently undergoing treatment for cancer (basal cell carcinoma is acceptable); * Body Mass Index (BMI) ≥ 50; * Women participating in Part 1 of study: Women with a history of loop electrosurgical excision procedure (LEEP) or cold knife conization without an intervening vaginal delivery; * Women with an intra-uterine device (IUD) in place, had an IUD removed within 30 days of the screening visit or scheduled to have an IUD inserted during the hysteroscopy procedure; * Women using NuvaRing® for contraception; * Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients; * Unable to comply with the protocol.