Bacterial VaginosisPhase 1NCT00537576
Safety Study of Lactobacillus Administered Vaginally to Healthy Women
A Phase 1 study testing Low dose LACTIN-V applicator, Medium dose LACTIN-V applicator and High dose LACTIN-V applicator in people with Bacterial Vaginosis, run by Osel, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Low dose LACTIN-V applicator, Medium dose LACTIN-V applicator and High dose LACTIN-V applicator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pre-menopausal women 18- 40 years of age at date of screening.
- Regular menstrual cycles (21-35 days) or amenorrheic for at least 3 months (long acting progestin contraceptives).
- Normal Pap smear collected at the screening visit.
- Previous sexual experience including vaginal intercourse.
- Previous experience of gynecological examinations.
- Currently in a mutually monogamous sexual relationship or not sexually active.
Show all 9Show fewer
- Agree to be sexually abstinent thoughout the trial.
- Agree to abstain from the use of any other intravaginal product thoughout the trial
- Agree to use an adequate method of birth control for the duration of the study to avoid pregnancy.
Who cannot join
- Urogenital infection at screening or within the 21 days prior to screening (UTI, bacterial vaginosis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum or Herpes simplex).
- History of recurrent genital herpes.
- Diagnosis of N. gonorrhoeae, C. trachomatis, T. pallidum or T. vaginalis on two or more occasions during the six months prior to screening.
- Pregnancy or within 2 months of last pregnancy.
- Lactation.
- Antibiotic or antifungal therapy within 30 days of enrollment visit.
Show all 18Show fewer
- Concurrent investigational drug use within 30 days or 10 half-lives of the drug, of enrollment visit or during the study.
- Menopause.
- IUD insertion or removal, pelvic surgery, cervical cryotherapy or cervical laser within the last 3 months.
- Use of a NuvaRing® within 3 days of the screening visit or during the course of the study.
- New (less than 3 months)long-acting treatments (e.g. depot formulation including medroxyprogesterone acetate (DMPA) form of hormonal birth control). - - Diabetes or other significant disease or acute illness.
- Known HIV infection or positive HIV test at screening.
- Immunosuppressive drug within 60 days.
- Previous participation in a L. crispatus CTV-05 clinical study.
- Colposcopic findings at the enrollment visit involving significant deep disruption of the epithelium.
- Abnormal results for the pap smear at the screening visit.
- Known allergy to any component of LACTIN-V, other significant drug allergy or to latex (condoms).
- Known drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women
The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study hypothesis is that LACTIN-V will be safe, tolerable, and acceptable at each dose and will not differ significantly from the placebo controls.
Read the detailed description
The purpose of this study is to demonstrate that LACTIN-V is safe, well tolerated, and acceptable to healthy pre-menopausal women when administered vaginally using pre-filled applicators at doses of 150 mg (5.0 x 10^8 CFU), 300 mg (1.0 x 10^9 CFU), or 600 mg (2.0 x 10^9 CFU) daily for 5 consecutive days as compared to placebo applicators containing 150 mg, 300 mg, or 600 mg of a matching placebo formulation without Lactobacillus crispatus CTV-05.
Safety will be assessed by:
- Incidence and severity of adverse events through assessing symptoms, physical examination findings, and signs of irritation involving the external genitalia, cervix or vagina, including disruption of the epithelium and blood vessels as seen on pelvic examination and colposcopy.
- Laboratory parameters including urinalysis, a complete blood count (CBC) with differential, and chemistry panels to assess systemic effects of the study product.
Tolerability will be assessed by:
- The proportion of participants who discontinue study product use due to overt adverse events
- The proportion of participants who complete the full dosing schedule
Acceptability will be assessed by:
- Self-administered questionnaires and focus group discussions about acceptability of the study product
- Conditions
- Bacterial Vaginosis
- Being tested
- Low dose LACTIN-V applicator, Medium dose LACTIN-V applicator, High dose LACTIN-V applicator, Low dose Placebo applicator, Medium dose Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose LACTIN-V applicatorBiological
Also called Lactobacillus crispatus CTV-05
Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days
Medium dose LACTIN-V applicatorBiological
Also called Lactobacillus crispatus CTV-05
Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
High dose LACTIN-V applicatorBiological
Also called Lactobacillus crispatus CTV-05
High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
Low dose Placebo applicatorOther
Also called Control substance
Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
Medium dose PlaceboOther
Also called Control substance
Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
High dose Placebo applicatorOther
Also called Control substance
High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Low dose LACTIN-V applicator | Experimental | Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days Receives: Biological: Low dose LACTIN-V applicator |
| Medium dose LACTIN-V applicator | Experimental | Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days Receives: Biological: Medium dose LACTIN-V applicator |
| High dose LACTIN-V applicator | Experimental | High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days Receives: Biological: High dose LACTIN-V applicator |
| Low dose Placebo applicator | Placebo comparator | Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days Receives: Other: Low dose Placebo applicator |
| Medium dose Placebo applicator | Placebo comparator | Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days Receives: Other: Medium dose Placebo |
| High dose Placebo applicator | Placebo comparator | High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days Receives: Other: High dose Placebo applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of LACTIN-V in Healthy Pre-menopausal Women.
Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.
Measured: 35 days
Secondary outcomes (2)
Tolerability of LACTIN-V in a Pre-filled Applicator.
Tolerability was measured as proportion of women remaining in the study, and NOT prematurely exiting the trial due to an adverse event.
Measured: 35 days
Acceptability of LACTIN-V in Pre-filled Applicators
Acceptability and overall satisfaction with the study product was measured using the response to the following question: "I would use the product again" with the following response options (strongly agree, agree, neutral, disagree, strongly disagree)
Acceptability is reported as the number of women in each group who strongly agreed or agreed with the statement that they would use the product again.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Craig Cohen, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537576
- Sponsor's protocol ID
- LV-005
- Status last verified
- Apr 2014
- First submitted
- 27 Sep 2007
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Giorgi A, Torriani S, Dellaglio F, Bo G, Stola E, Bernuzzi L. Identification of vaginal lactobacilli from asymptomatic women. Microbiologica. 1987 Oct;10(4):377-84.
PubMed 3695985Antonio MA, Hawes SE, Hillier SL. The identification of vaginal Lactobacillus species and the demographic and microbiologic characteristics of women colonized by these species. J Infect Dis. 1999 Dec;180(6):1950-6. doi: 10.1086/315109.
PubMed 10558952Antonio MA, Hillier SL. DNA fingerprinting of Lactobacillus crispatus strain CTV-05 by repetitive element sequence-based PCR analysis in a pilot study of vaginal colonization. J Clin Microbiol. 2003 May;41(5):1881-7. doi: 10.1128/JCM.41.5.1881-1887.2003.
PubMed 12734221Sobel JD. Vaginitis in adult women. Obstet Gynecol Clin North Am. 1990 Dec;17(4):851-79.
PubMed 2092246Thomason JL, Gelbart SM, Scaglione NJ. Bacterial vaginosis: current review with indications for asymptomatic therapy. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1210-7. doi: 10.1016/s0002-9378(12)90729-2.
PubMed 1951577Pastore LM, Thorp JM Jr, Royce RA, Savitz DA, Jackson TP. Risk score for antenatal bacterial vaginosis: BV PIN points. J Perinatol. 2002 Mar;22(2):125-32. doi: 10.1038/sj.jp.7210654.
PubMed 11896517Gibney L, Macaluso M, Kirk K, Hassan MS, Schwebke J, Vermund SH, Choudhury P. Prevalence of infectious diseases in Bangladeshi women living adjacent to a truck stand: HIV/STD/hepatitis/genital tract infections. Sex Transm Infect. 2001 Oct;77(5):344-50. doi: 10.1136/sti.77.5.344.
PubMed 11588280Kamara P, Hylton-Kong T, Brathwaite A, Del Rosario GR, Kristensen S, Patrick N, Weiss H, Figueroa PJ, Vermund SH, Jolly PE. Vaginal infections in pregnant women in Jamaica: prevalence and risk factors. Int J STD AIDS. 2000 Aug;11(8):516-20. doi: 10.1258/0956462001916425.
PubMed 10990336Goldenberg RL, Klebanoff MA, Nugent R, Krohn MA, Hillier S, Andrews WW. Bacterial colonization of the vagina during pregnancy in four ethnic groups. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1996 May;174(5):1618-21. doi: 10.1016/s0002-9378(96)70617-8.
PubMed 9065140Sewankambo N, Gray RH, Wawer MJ, Paxton L, McNaim D, Wabwire-Mangen F, Serwadda D, Li C, Kiwanuka N, Hillier SL, Rabe L, Gaydos CA, Quinn TC, Konde-Lule J. HIV-1 infection associated with abnormal vaginal flora morphology and bacterial vaginosis. Lancet. 1997 Aug 23;350(9077):546-50. doi: 10.1016/s0140-6736(97)01063-5.
PubMed 9284776Jurney TH, de Ruyter H, Vigersky RA. Cushing's disease presenting as amenorrhoea with hyperprolactinaemia: report of two cases. Clin Endocrinol (Oxf). 1981 Jun;14(6):539-45. doi: 10.1111/j.1365-2265.1981.tb02963.x.
PubMed 7197596Hay PE, Lamont RF, Taylor-Robinson D, Morgan DJ, Ison C, Pearson J. Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. BMJ. 1994 Jan 29;308(6924):295-8. doi: 10.1136/bmj.308.6924.295.
PubMed 8124116Eschenbach DA. Bacterial vaginosis and anaerobes in obstetric-gynecologic infection. Clin Infect Dis. 1993 Jun;16 Suppl 4:S282-7. doi: 10.1093/clinids/16.supplement_4.s282.
PubMed 8324132Hawes SE, Hillier SL, Benedetti J, Stevens CE, Koutsky LA, Wolner-Hanssen P, Holmes KK. Hydrogen peroxide-producing lactobacilli and acquisition of vaginal infections. J Infect Dis. 1996 Nov;174(5):1058-63. doi: 10.1093/infdis/174.5.1058.
PubMed 8896509Puapermpoonsiri S, Kato N, Watanabe K, Ueno K, Chongsomchai C, Lumbiganon P. Vaginal microflora associated with bacterial vaginosis in Japanese and Thai pregnant women. Clin Infect Dis. 1996 Oct;23(4):748-52. doi: 10.1093/clinids/23.4.748.
PubMed 8909838
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women
- ClinicalTrials.gov ID
- NCT00537576
- Acronym / sponsor ID
- LV-005
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Osel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- Nov 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study hypothesis is that LACTIN-V will be safe, tolerable, and acceptable at each dose and will not differ significantly from the placebo controls.
Detailed description
The purpose of this study is to demonstrate that LACTIN-V is safe, well tolerated, and acceptable to healthy pre-menopausal women when administered vaginally using pre-filled applicators at doses of 150 mg (5.0 x 10^8 CFU), 300 mg (1.0 x 10^9 CFU), or 600 mg (2.0 x 10^9 CFU) daily for 5 consecutive days as compared to placebo applicators containing 150 mg, 300 mg, or 600 mg of a matching placebo formulation without Lactobacillus crispatus CTV-05.
Safety will be assessed by:
- Incidence and severity of adverse events through assessing symptoms, physical examination findings, and signs of irritation involving the external genitalia, cervix or vagina, including disruption of the epithelium and blood vessels as seen on pelvic examination and colposcopy.
- Laboratory parameters including urinalysis, a complete blood count (CBC) with differential, and chemistry panels to assess systemic effects of the study product.
Tolerability will be assessed by:
- The proportion of participants who discontinue study product use due to overt adverse events
- The proportion of participants who complete the full dosing schedule
Acceptability will be assessed by:
- Self-administered questionnaires and focus group discussions about acceptability of the study product
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low dose LACTIN-V applicator | Experimental | Biological: Low dose LACTIN-V applicatorLow dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days |
| Medium dose LACTIN-V applicator | Experimental | Biological: Medium dose LACTIN-V applicatorMedium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days |
| High dose LACTIN-V applicator | Experimental | Biological: High dose LACTIN-V applicatorHigh dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days |
| Low dose Placebo applicator | Placebo comparator | Other: Low dose Placebo applicatorLow dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days |
| Medium dose Placebo applicator | Placebo comparator | Other: Medium dose PlaceboMedium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days |
| High dose Placebo applicator | Placebo comparator | Other: High dose Placebo applicatorHigh dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy pre-menopausal women 18- 40 years of age at date of screening.
- Regular menstrual cycles (21-35 days) or amenorrheic for at least 3 months (long acting progestin contraceptives).
- Normal Pap smear collected at the screening visit.
- Previous sexual experience including vaginal intercourse.
- Previous experience of gynecological examinations.
Key exclusion criteria (18 listed)
- Urogenital infection at screening or within the 21 days prior to screening (UTI, bacterial vaginosis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum or Herpes simplex).
- History of recurrent genital herpes.
- Diagnosis of N. gonorrhoeae, C. trachomatis, T. pallidum or T. vaginalis on two or more occasions during the six months prior to screening.
- Pregnancy or within 2 months of last pregnancy.
- Lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose LACTIN-V applicatorAlso: Lactobacillus crispatus CTV-05Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days | Biological | Low dose LACTIN-V applicator |
| Medium dose LACTIN-V applicatorAlso: Lactobacillus crispatus CTV-05Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days | Biological | Medium dose LACTIN-V applicator |
| High dose LACTIN-V applicatorAlso: Lactobacillus crispatus CTV-05High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days | Biological | High dose LACTIN-V applicator |
| Low dose Placebo applicatorAlso: Control substanceLow dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days | Other | Low dose Placebo applicator |
| Medium dose PlaceboAlso: Control substanceMedium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days | Other | Medium dose Placebo applicator |
| High dose Placebo applicatorAlso: Control substanceHigh dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days | Other | High dose Placebo applicator |
Primary outcome
Safety of LACTIN-V in Healthy Pre-menopausal Women.
Time frame: 35 days
Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.
2 secondary outcomes
Tolerability of LACTIN-V in a Pre-filled Applicator.
Time frame: 35 days
Acceptability of LACTIN-V in Pre-filled Applicators
Time frame: 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3695985Giorgi A, Torriani S, Dellaglio F, Bo G, Stola E, Bernuzzi L. Identification of vaginal lactobacilli from asymptomatic women. Microbiologica. 1987 Oct;10(4):377-84.
- Background: PubMed 10558952Antonio MA, Hawes SE, Hillier SL. The identification of vaginal Lactobacillus species and the demographic and microbiologic characteristics of women colonized by these species. J Infect Dis. 1999 Dec;180(6):1950-6. doi: 10.1086/315109.
- Background: PubMed 12734221Antonio MA, Hillier SL. DNA fingerprinting of Lactobacillus crispatus strain CTV-05 by repetitive element sequence-based PCR analysis in a pilot study of vaginal colonization. J Clin Microbiol. 2003 May;41(5):1881-7. doi: 10.1128/JCM.41.5.1881-1887.2003.
- Background: PubMed 2092246Sobel JD. Vaginitis in adult women. Obstet Gynecol Clin North Am. 1990 Dec;17(4):851-79.
- Background: PubMed 1951577Thomason JL, Gelbart SM, Scaglione NJ. Bacterial vaginosis: current review with indications for asymptomatic therapy. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1210-7. doi: 10.1016/s0002-9378(12)90729-2.
- Background: PubMed 11896517Pastore LM, Thorp JM Jr, Royce RA, Savitz DA, Jackson TP. Risk score for antenatal bacterial vaginosis: BV PIN points. J Perinatol. 2002 Mar;22(2):125-32. doi: 10.1038/sj.jp.7210654.
- Background: PubMed 11588280Gibney L, Macaluso M, Kirk K, Hassan MS, Schwebke J, Vermund SH, Choudhury P. Prevalence of infectious diseases in Bangladeshi women living adjacent to a truck stand: HIV/STD/hepatitis/genital tract infections. Sex Transm Infect. 2001 Oct;77(5):344-50. doi: 10.1136/sti.77.5.344.
- Background: PubMed 10990336Kamara P, Hylton-Kong T, Brathwaite A, Del Rosario GR, Kristensen S, Patrick N, Weiss H, Figueroa PJ, Vermund SH, Jolly PE. Vaginal infections in pregnant women in Jamaica: prevalence and risk factors. Int J STD AIDS. 2000 Aug;11(8):516-20. doi: 10.1258/0956462001916425.
- Background: PubMed 9065140Goldenberg RL, Klebanoff MA, Nugent R, Krohn MA, Hillier S, Andrews WW. Bacterial colonization of the vagina during pregnancy in four ethnic groups. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1996 May;174(5):1618-21. doi: 10.1016/s0002-9378(96)70617-8.
- Background: PubMed 9284776Sewankambo N, Gray RH, Wawer MJ, Paxton L, McNaim D, Wabwire-Mangen F, Serwadda D, Li C, Kiwanuka N, Hillier SL, Rabe L, Gaydos CA, Quinn TC, Konde-Lule J. HIV-1 infection associated with abnormal vaginal flora morphology and bacterial vaginosis. Lancet. 1997 Aug 23;350(9077):546-50. doi: 10.1016/s0140-6736(97)01063-5.
- Background: PubMed 7197596Jurney TH, de Ruyter H, Vigersky RA. Cushing's disease presenting as amenorrhoea with hyperprolactinaemia: report of two cases. Clin Endocrinol (Oxf). 1981 Jun;14(6):539-45. doi: 10.1111/j.1365-2265.1981.tb02963.x.
- Background: PubMed 8124116Hay PE, Lamont RF, Taylor-Robinson D, Morgan DJ, Ison C, Pearson J. Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. BMJ. 1994 Jan 29;308(6924):295-8. doi: 10.1136/bmj.308.6924.295.
- Click here for more information about this study: LACTIN-V phase I studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Cohen, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose LACTIN-V applicator, Medium dose LACTIN-V applicator and High dose LACTIN-V applicator in people with Bacterial Vaginosis, run by Osel, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of LACTIN-V in Healthy Pre-menopausal Women. (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00537576, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.