CompletedNCT00274261Updated May 1, 2018Results posted

Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

A Phase 3 interventional study of C31G and nonoxynol-9 (N-9) in Pregnancy, sponsored by Health Decisions. Completed at 15 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Health Decisions · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 1,565
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: Female

Study 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. 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 studied

Pregnancy

Keywords

contraception

In context

Lead sponsor

Health Decisions is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Potential subjects must:

Be healthy women, who are sexually active, at risk for pregnancy and desiring .
Be within the age range of 18 through 40 years inclusive.
Be at low-risk for (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.
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 to participate in the trial.

Exclusion criteria

Exclusion Criteria:

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.
Have any 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 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 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 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 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.

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 1,565 participants (actual)

Study arms

Experimental
A
C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
Drug: C31G
Active comparator
B
Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
Drug: nonoxynol-9 (N-9)

Interventions

DrugC31G
The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.
Drugnonoxynol-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.

What researchers measure

Primary outcomes

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.
Time frame: 6 months

Secondary outcomes

Incidence of Adverse Events.
Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.
Time frame: duration of the study - through 6 month or 12 months of use

Results

Posted Jun 6, 2013

Participant flow

Female subjects were screened and enrolled at 15 sites in the US.

Participant flow — Overall Study
Milestone	C31G	Conceptrol
Started	932	633
Completed	443	296
Not completed	489	337
Withdrew: Adverse event	19	11
Withdrew: Pregnancy	114	83
Withdrew: Withdrawal by subject	179	126
Withdrew: Protocol violation	71	42
Withdrew: Lost to follow-up	106	75

Outcome measures

PrimaryThe 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.

Time frame:: 6 months
Reported as:: Number · 6 month probability of pregnancy

The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.
6 month probability of pregnancy	C31G	Conceptrol
The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.	0.12 (0.093 to 0.147)	0.12 (0.087 to 0.153)

SecondaryIncidence of Adverse Events.

Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.

Time frame:: duration of the study - through 6 month or 12 months of use
Reported as:: Count of participants · Participants

Incidence of Adverse Events.
Participants	C31G Vaginal Gel	Conceptrol® Vaginal Gel
Incidence of Adverse Events.	617	434

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
C31G	—	10/836 (1.2%)	617/836 (73.8%)
Conceptrol	—	12/560 (2.1%)	434/560 (77.5%)

Most frequent serious events

Showing 10 of 27

Most frequent serious events
Event	C31G	Conceptrol
PalpitationsCardiac disorders	0/836	1/560
Diabetic ketoacidosisEndocrine disorders	0/836	1/560
Gastroenteritis escherichia coliGastrointestinal disorders	0/836	1/560
Gastrointestinal painGastrointestinal disorders	0/836	1/560
NauseaGastrointestinal disorders	0/836	1/560
Bile duct stoneHepatobiliary disorders	0/836	1/560
HypersensitivityImmune system disorders	0/836	1/560
InfectionInfections and infestations	0/836	1/560
LacerationInjury, poisoning and procedural complications	0/836	1/560
HypoglycaemiaMetabolism and nutrition disorders	0/836	1/560

Most frequent other events

Showing 10 of 23

Most frequent other events
Event	C31G	Conceptrol
NasopharygitisInfections and infestations	130/836	92/560
Vaginitis bacterialInfections and infestations	100/836	73/560
Vaginal mycosisInfections and infestations	87/836	70/560
HeadacheNervous system disorders	79/836	63/560
Urinary tract infectionInfections and infestations	79/836	59/560
MetrorrhagiaReproductive system and breast disorders	69/836	55/560
Menstrual cycle prolongedReproductive system and breast disorders	57/836	41/560
Menstruation irregularReproductive system and breast disorders	56/836	41/560
InfluenzaInfections and infestations	57/836	35/560
DysmenorrhoeaReproductive system and breast disorders	49/836	37/560

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	C31G	Conceptrol	Total
<=18 years	0	0	0
Between 18 and 65 years	932	633	1565
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	C31G	Conceptrol	Total
Mean	28.1 ± 5.58	28.3 ± 5.90	28.2 ± 5.71

Sex: Female, Male
Sex: Female, Male(Participants)	C31G	Conceptrol	Total
Female	932	633	1565
Male	0	0	0

Region of Enrollment
Region of Enrollment(participants)	C31G	Conceptrol	Total
United States	932	633	1565

Study locations

15 sites

California Family Health Council
Berkeley, California 94710, United States
California Family Health Council
Los Angeles, California 90010, United States
University of Colorado - Advanced reproductive Medicine
Aurora, Colorado 80010, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224, United States
Bay State Medical Center
Springfield, Massachusetts 01199, United States
New York University
New York, New York 10016, United States
Columbia University
New York, New York 10032, United States
University of Cincinnati
Cincinnati, Ohio 45267, United States
University Hospitals of Cleveland MacDonald Women's Hospital
Cleveland, Ohio 44106, United States
The Ohio State University College of Medicine
Columbus, Ohio 43210, United States
Oregon Health & Science University
Portland, Oregon 97239, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania 15213, United States
U.T. Southwestern Medical Center
Dallas, Texas 75390, United States
Jones Institute of Reproductive Medicine, EVMS
Norfolk, Virginia 23507, United States

References and documents

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 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2004, a primary completion of Jul 2008 and a completion of Sep 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2013, 4 years 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 6, 2006
First posted: Jan 10, 2006
Start: Jun 2004
Primary completionActual: Jul 2008
CompletionActual: Sep 2008
Results first posted: Jun 6, 2013
Last update: May 1, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00274261
Lead sponsor: Health Decisions
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party: Sponsor
First posted: Jan 10, 2006
Start date: Jun 2004
Primary completion: Jul 2008
Completion: Sep 2008
Results posted: Jun 6, 2013
Last update: May 1, 2018

Study contacts

Diana L Blithe, Ph.D.

study director · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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