GoldenCareTM for the Treatment of Bacterial Vaginosis

C

CDA Research Group

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Bacterial Vaginosis

Treatments

Drug: Metronidazole
Drug: GoldenCare

Study type

Interventional

Funder types

Industry

Identifiers

NCT01762670
CDA 1106

Details and patient eligibility

About

GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial Vaginosis (BV). Standard treatment for BV is metronidazole. Although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare.

Full description

GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial Vaginosis(BV). Standard treatment for BV is metronidazole. Although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare.

Enrollment

8 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent
  • Female aged 18 years or older
  • Subject has clinical bacterial Vaginosis with 4 of 4 positive Amsel's criteria
  • Negative pregnancy test
  • For 7 day treatment period, subject agrees to refrain from using douches and intravaginal products (i.e. feminine deodorant sprays, spermicides, Nonoxynol-9 products, tampons, and condoms). Subject also agrees to refrain from taking oral or intravaginal antibiotics (unless enrolled in comparator arm),or antifungal agents during the entire study period.

Exclusion criteria

  • Subject has another infectious or noninfectious cause of vulvovaginitis such asymptomatic candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, human papilloma virus, atrophic vaginitis, lichen sclerosus, or genital warts.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

8 participants in 2 patient groups

Metronidazole
Active Comparator group
Description:
Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days
Treatment:
Drug: Metronidazole
GoldenCare
Experimental group
Description:
GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights.
Treatment:
Drug: GoldenCare

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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