Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Brian Sanderson


Contact details

Drug Development Solutions Limited
Ninewells Hospital and Medical School
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

This study is to confirm the safety, tolerability and the pharmacokinetic profile of the hydrochloride forumation in healthy female volunteers. This treatment is expected to be effective in the treatment of patients diagnosed with bacterial vaginosis.

The concentrations of clindamycin (fee base) in plasma at pre-determined time-points.

Please note that as of 18/10/2007 the anticipated end date of this trial was extended from 09/10/2007.

Ethics approval

Tayside Committee on Medical Research Ethics B, 21/08/2007, ref: 07/S1402/63

Study design

Phase I single-centre non-randomised non-controlled open study

Primary study design


Secondary study design


Trial setting

Not specified

Trial type


Patient information sheet


Bacterial vaginosis


Pre-trial visit:
Prior to interventions, written informed consent will be gained. A screening assessment and a compliance check will be performed the day before dosing.

Day one:
Pre-dose checks, vitals, menstrual history check, a pre-dose pharmacokinetic (PK) sample and vaginal pH testing will be performed, and a check to see if the volunteer has any signs or symptoms of infection will also be performed.

After this, the study drug (100 mg Clindamycin Hydrochloride Vaginal Insert) will be administered (dosing period = 24 hours). Post insertion checks will include comfort questionnaires, PK blood samples, vitals and vaginal pH. The study drug will be removed at 24 hours and a urine sample for urinalysis will be taken.

Day two:
PK blood samples will be taken.

Days 3, 4, 5 and 6:
PK blood sample, vitals and urine sample for urinalysis information will be taken.

Adverse Events (AEs) and concomitant medication checks will be performed throughout the trial.

Post-trial visit:
Vitals, Electrocardiogram (ECG), safety bloods and urine samples, urine for pregnancy testing and a physical examination will be performed.

Intervention type



Phase I

Drug names


Primary outcome measure

The concentrations of clindamycin (free base) in plasma at pre-determined time-points.

Secondary outcome measures

1. Assessments of all adverse events reported
2. Assessment of tolerability by review of completed comfort questionnaires
3. Assessment of vaginal pH at specified time-points
4. Measurements of residual amounts of clindamycin in used CHVI to calculate the remaining dose of clindamycin in order to determine the amount of drug released from the insert

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Drug Development Solutions Limited
United Kingdom

Sponsor information


Controlled Therapeutics (Scotland) Ltd (UK)

Sponsor details

1 Redwood Place
Peel Park Campus
East Kilbride
G74 5PB
United Kingdom

Sponsor type




Funder type


Funder name

Controlled Therapeutics (Scotland) Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

See additional file (ISRCTN 15152571_Basic Results_12Nov19)

Publication list

Publication citations

Additional files

Editorial Notes

12/11/2019: The basic results of this trial have been uploaded as an additional file. 30/10/2019: No publications found, verifying study status with principal investigator.