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

NCT00925938 | Completed Phase 2 Results DMC

• 1 other identifier: Miso-Gyn-201
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office hysteroscopy procedure. Each subject will be randomized to receive one vaginal insert. The study drug will be administered vaginally by a member of the clinical research team (Part I) or insert herself (Part II) 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The internal os of the cervix will be measured at baseline, just prior to the hysteroscopy and at the follow up visit. The primary outcome measure is change in diameter of the internal cervical os from baseline (pre-treatment) to just prior to the hysteroscopy procedure (post-treatment). The hypothesis is that treatment with the MVPI will soften and dilate the cervix better than placebo.

Conditions

Cervical Priming

Keywords

Hysteroscopy; Cervical priming; Cervical dilatation; Misoprostol; Endoscopy, uterine

Outcome Measures

Primary Outcomes (1)

• Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment).

  Baseline to 18-24 hours

Secondary Outcomes (4)

• Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access

  18 - 24 hours

• Total Procedure Time From Insertion of the First Hegar Dilator to Completion of the Hysteroscopy Procedure;

  18 - 24 hours

• Physician Assessment of Ease of Cervical Dilation;

  18 - 24 hours

• Percentage of Participants With Adverse Events

  9 days

Study Arms (2)

Misoprostol vaginal priming insert (MVPI)

EXPERIMENTAL

One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The initial dose is 400 mcg and dose will be adjusted between 100 - 1600 mcg after each study cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB).

Drug: misoprostol

MVPI Placebo

PLACEBO COMPARATOR

One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.

Drug: placebo

Interventions

misoprostol DRUG

One vaginal insert containing 100, 200, 400, 800, 1200, 1600 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure. An adaptive design will be used to determine whether to escalate or reduce the dose, starting with MVPI 400 mcg.

Misoprostol vaginal priming insert (MVPI)

placebo DRUG

placebo

MVPI Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (2)

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 22, 2009
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 13, 2014
• Results First Posted: December 13, 2013

Record last verified: 2014-01

Locations

US (2)