PregnancyPhase 3NCT00274261
Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
A Phase 3 study testing C31G and nonoxynol-9 (N-9) in people with Pregnancy, run by Premier Research at 15 sites in United States.
Trial summary
This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. 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
- Pregnancy
- What is being tested?
- C31G and nonoxynol-9 (N-9)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,565 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2004to Sep 2008
- Phase
- Phase 3
- 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
- Potential subjects must:
- Be healthy women, who are sexually active, at risk for pregnancy and desiring contraception.
- Be within the age range of 18 through 40 years inclusive.
- Be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease (STD) infection and currently have a single sex partner (minimum 4 months) who is also at low-risk for HIV or STD.
- Have a negative urine pregnancy test prior to enrollment.
- Have normal cyclic menses with a usual length of 24 to 35 days over the last 2 cycles or at least one spontaneous, normal menstrual cycle (2 menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy.
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- Be willing to accept a risk of pregnancy.
- Be willing to engage in at least 4 acts of heterosexual vaginal intercourse per month for a period of 6 months.
- Be willing to be randomized to either study treatment.
- Be willing to only use the study product as the primary method of contraception over the course of the study with the exception of emergency contraception (EC), when indicated.
- Be capable of using the study product properly and agree to observe all study directions and requirements.
- Be willing to keep a diary to record coital information, product use information, information about the use of other vaginal products, and sign and symptom data of subject and partner.
- Agree not to participate in any other clinical trials during the course of the study.
- Be willing to give written informed consent to participate in the trial.
Who cannot join
- Potential subjects must not:
- Have a history of allergy or sensitivity to spermicides or products containing N-9.
- Have had 3 or more urinary tract infections (UTI) in the past year.
- Have UTI by urine culture or symptomatic yeast vaginitis or symptomatic bacterial vaginosis diagnosed by wet mount unless treated and proof of cure is documented.
- Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
- Have a history of infertility or of conditions that may lead to infertility, without subsequent intrauterine pregnancy.
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- Have any contraindications to pregnancy (medical condition) or chronic use of category D or X medications.
- Have had more than one sexual partner in the last 4 months.
- Have shared injection drug needles within the past 12 months.
- Have or have been suspected to have HIV infection.
- Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within three months prior to screening.
- Have 3 or more outbreaks of HSV within the last year.
- Have been diagnosed with any other STDs (including trichomonas) in the 6 months prior to the screening visit (with the exception of Human Papilloma Virus [HPV]).
- Be lactating or breastfeeding.
- Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.
- Have any clinically significant abnormal finding on pelvic examination or baseline labs, which in the view of the investigator, precludes her from participating in the trial.
- Have clinically significant signs of vaginal or cervical irritation on pelvic examination.
- Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening.
- Have used vaginal or systemic antibiotics or antifungals within 14 days prior to screening or randomization.
- Have had a Depo-Provera® injection in the 10 months prior to enrollment.
- Have an abnormal Pap smear with high grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC) or ASC-H (atypical squamous cells, cannot exclude HSIL) within the last 12 months.
- Have an abnormal Pap smear with low-grade squamous intraepithelial lesion (LSIL) or ASCUS-HPV HR positive unless resolved by colposcopy.
- Have a Cervical Intraepithelial Neoplasia (CIN) diagnosis by biopsy within the last 12 months.
- Have a history or a current diagnosis of cervical cancer.
- Consume (on average) greater than three drinks of an alcoholic beverage per day.
- Have a past history (within twelve months) or current history of drug abuse [recreational, prescription or over-the-counter (OTC)].
- Have taken an investigational drug or used an investigational device within the past 30 days.
- Have previously participated in or completed this study or any other phase III study of C31G.
- Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Colorado - Advanced reproductive Medicine
Aurora, Colorado, 80010
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
California Family Health Council
Berkeley, California, 94710
University of Cincinnati
Cincinnati, Ohio, 45267
University Hospitals of Cleveland MacDonald Women's Hospital
Cleveland, Ohio, 44106
The Ohio State University College of Medicine
Columbus, Ohio, 43210
U.T. Southwestern Medical Center
Dallas, Texas, 75390
California Family Health Council
Los Angeles, California, 90010
New York University
New York, New York, 10016
Columbia University
New York, New York, 10032
Jones Institute of Reproductive Medicine, EVMS
Norfolk, Virginia, 23507
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
Bay State Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study treatment for up to twelve months (365 days) and twelve cycles of treatment upon completion of the first six months of treatment.
Read the detailed description
Approximately 85% of American women (52 million) between the ages of 15 and 44 are sexually active . Approximately two-thirds or 38 million women use some form of birth control and/or STD prevention. With growing awareness of the risk of STDs, increasing numbers of women will require contraceptive methods that provide protection against STDs in addition to providing the basic contraceptive function. Currently there is no single, reasonably effective method to achieve both ends. Condoms, both male and female, present problems of acceptability for the partners of many at-risk women and, thus, cannot be considered an effective contraceptive and STD preventive for many people. A spermicide that also has the ability to prevent transmission of STDs would be a major advance, and of tremendous value to women worldwide.
C31G is an effective spermicide with in vitro activity equal to that of N-9 . C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. It is also active against enveloped viruses including HIV and HSV. Thus, the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol® Vaginal Gel. The secondary objectives are to determine the safety and acceptability of the compounds with use over a period of six months or twelve months. Additional evaluations include the incidence of urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol® Vaginal Gel.
- Conditions
- Pregnancy
- Being tested
- C31G, nonoxynol-9 (N-9)
- Keywords
- contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C31GDrug
The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.
nonoxynol-9 (N-9)Drug
The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel Receives: Drug: C31G |
| B | Active comparator | Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel. Receives: Drug: nonoxynol-9 (N-9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.
Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.
Measured: 6 months
Secondary outcomes (1)
Incidence of Adverse Events.
Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.
Measured: duration of the study - through 6 month or 12 months of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJun 2004
- Primary completionJul 2008
- Study completionSep 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 (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premier Research
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Diana L Blithe, Ph.D., Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274261
- Sponsor's protocol ID
- CCN004
- Other IDs
- HHSN2752004033661
- Status last verified
- Apr 2018
- First submitted
- 6 Jan 2006
- Last updated
- 1 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Burke AE, Barnhart K, Jensen JT, Creinin MD, Walsh TL, Wan LS, Westhoff C, Thomas M, Archer D, Wu H, Liu J, Schlaff W, Carr BR, Blithe D. Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1265-1273. doi: 10.1097/AOG.0b013e3181fc3b1a.
PubMed 21099590
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
- ClinicalTrials.gov ID
- NCT00274261
- Acronym / sponsor ID
- CCN004
- Conditions
- Pregnancy
- Keywords
- contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,565 participants (actual)
- Lead sponsor
- Premier ResearchUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 10 Jan 2006 (estimated)
- Results
- Posted 6 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study treatment for up to twelve months (365 days) and twelve cycles of treatment upon completion of the first six months of treatment.
Detailed description
Approximately 85% of American women (52 million) between the ages of 15 and 44 are sexually active . Approximately two-thirds or 38 million women use some form of birth control and/or STD prevention. With growing awareness of the risk of STDs, increasing numbers of women will require contraceptive methods that provide protection against STDs in addition to providing the basic contraceptive function. Currently there is no single, reasonably effective method to achieve both ends. Condoms, both male and female, present problems of acceptability for the partners of many at-risk women and, thus, cannot be considered an effective contraceptive and STD preventive for many people. A spermicide that also has the ability to prevent transmission of STDs would be a major advance, and of tremendous value to women worldwide.
C31G is an effective spermicide with in vitro activity equal to that of N-9 . C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. It is also active against enveloped viruses including HIV and HSV. Thus, the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol® Vaginal Gel. The secondary objectives are to determine the safety and acceptability of the compounds with use over a period of six months or twelve months. Additional evaluations include the incidence of urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol® Vaginal Gel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: C31GC31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel |
| B | Active comparator | Drug: nonoxynol-9 (N-9)Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Be healthy women, who are sexually active, at risk for pregnancy and desiring contraception.
- Be within the age range of 18 through 40 years inclusive.
- Be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease (STD) infection and currently have a single sex partner (minimum 4 months) who is also at low-risk for HIV or STD.
- Have a negative urine pregnancy test prior to enrollment.
- Have normal cyclic menses with a usual length of 24 to 35 days over the last 2 cycles or at least one spontaneous, normal menstrual cycle (2 menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy.
Key exclusion criteria (29 listed)
- Have a history of allergy or sensitivity to spermicides or products containing N-9.
- Have had 3 or more urinary tract infections (UTI) in the past year.
- Have UTI by urine culture or symptomatic yeast vaginitis or symptomatic bacterial vaginosis diagnosed by wet mount unless treated and proof of cure is documented.
- Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
- Have a history of infertility or of conditions that may lead to infertility, without subsequent intrauterine pregnancy.
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 |
|---|---|---|
| C31GThe subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study. | Drug | A |
| nonoxynol-9 (N-9)The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study. | Drug | B |
Primary outcome
The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.
Time frame: 6 months
Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.
1 secondary outcome
Incidence of Adverse Events.
Time frame: duration of the study - through 6 month or 12 months of use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21099590Burke AE, Barnhart K, Jensen JT, Creinin MD, Walsh TL, Wan LS, Westhoff C, Thomas M, Archer D, Wu H, Liu J, Schlaff W, Carr BR, Blithe D. Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1265-1273. doi: 10.1097/AOG.0b013e3181fc3b1a.
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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.
Diana L Blithe, Ph.D. study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C31G and nonoxynol-9 (N-9) in people with Pregnancy, run by Premier Research at 15 sites 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 14 inclusion and 29 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 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Jun 2013). 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?
The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy. (time frame: 6 months). 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 NCT00274261, which also lists 1 linked publication.
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 1 May 2018.