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Clinical Trials/ISRCTN15152571
ISRCTN15152571
Completed
Phase 1

A phase I, single-centre, open study to assess the pharmacokinetic profile and safety of a 100 mg Clindamycin Hydrochloride Vaginal Insert (CHVI) in healthy females

Controlled Therapeutics (Scotland) Ltd (UK)0 sites10 target enrollmentOctober 4, 2007
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ConditionsBacterial vaginosisUrological and Genital DiseasesAcute vaginitis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bacterial vaginosis
Sponsor
Controlled Therapeutics (Scotland) Ltd (UK)
Enrollment
10
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 4, 2007
End Date
November 9, 2007
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Controlled Therapeutics (Scotland) Ltd (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Healthy female volunteers aged between 18 \- 50 years
  • •2\. Urine negative for a urinary tract infection
  • •3\. Up to date with regular pap smear tests in accordance with local health authority guidelines
  • •4\. Agree to refrain from placing anything on the following list in their vagina other than the study drug from the day of admission to the clinical trial unit until completion of the follow\-up visit:
  • •4\.1\. Use of 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 discharge from the clinic (Day 3\)
  • •4\.2\. Vaginal intercourse is permitted except for the 24\-hour period prior to admission and during the residential period of the study
  • •5\. Written informed consent

Exclusion Criteria

  • •1\. Volunteers expected to menstruate from Day 0 to Day 6 or during the 48 hours prior to dosing
  • •2\. Volunteers who have a vaginal pH of 4\.7 or higher and have any other signs or symptoms of infections at screening and prior to Dosing Day 1
  • •3\. Volunteers who have any significant history of drug allergies especially to clindamycin or lincomycin
  • •4\. Urinary tract infection in the previous 6 months or have a significant history of recurring urinary tract infections
  • •5\. Antimicrobial and/or antifungal therapy (systemic or intravaginal) within 14 days of dosing
  • •6\. Signs and/or symptoms of vaginal infection or infections within the last month or positive vaginal swab culture (to definite specific pathogens) at screening
  • •7\. Known current Sexually Transmitted Infection (STI) to be established by discussion
  • •8\. Contraindications for clindamycin per current labelling of marketed intravaginal formulations
  • •9\. Diagnosis or treatment in the previous 6 months for Cervical Intra\-epithelial Neoplasia (CIN) or cervical carcinoma

Outcomes

Primary Outcomes

Not specified

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