Contraceptive DevicePhase 1NCT00561613
Postcoital Testing of the SILCS Diaphragm
A Phase 1 study testing SILCS and lubricant and SILCS and spermicide in people with Contraceptive Device, run by CONRAD at 2 sites in United States.
Trial summary
This was a Phase I multi-center, randomized study in 40 healthy, sexually active women not at risk for pregnancy due to previous female sterilization. The male partners of the participants were consented to participate in the study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Device
- What is being tested?
- SILCS and lubricant and SILCS and spermicide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2003to Oct 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female Participants
- 18-45 years old (inclusive)
- In good general health based on medical history \& physical exam
- Previous bilateral tubal ligation or salpingectomy
- Regular menstrual cycles of 24-35 days (inclusive)
- Negative urine pregnancy test at admission
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- Not currently breast feeding
- No significant gynecological abnormalities
- Normal cervical Papanicolaou smear within 6 months preceding enrollment
- In a stable relationship with only one sexual partner
- Willing to undergo at least three PCTs
- Willing to abstain from intercourse and use of vaginal products
- Willing to use condoms from day 1 of each menstrual cycle until midcycle
- Male Participants
- Age 18 years and older
- Able and willing to provide written informed consent
- Willing to engage in intercourse with and without condoms
Who cannot join
- Female Participants
- History in subject of allergy to study products
- Positive wet mount for Trichomonas vaginalis
- History of any STD within 6 months of enrollment
- Device does not appropriately fit volunteer, as determined by clinician
- Inability to insert, position, and/or remove study device
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- Participation in another study within 30 days prior to enrollment
- Male Participants
- History of allergy to study products
- History of vasectomy
- In the six months prior to study, diagnosed with or treated for any STI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eastern Virginia Medical School
Norfolk, Virginia, 23507
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase I Postcoital Testing and Safety Study of the SILCS Diaphragm, Prototype VI
This was a Phase I multi-center, randomized study in 40 healthy, sexually active women not at risk for pregnancy due to previous female sterilization. The male partners of the participants were consented to participate in the study. The clinician evaluating the cervical mucus for midcycle characteristics and presence of sperm was blinded as to gel used. The product tested was the SILCS diaphragm with Gynol II (spermicide) and the SILCS diaphragm with KY Jelly (lubricant). The sequence of diaphragm and gel use was determined by randomization. The study was conducted at two centers, Magee-Womens Hospital in Pittsburgh, Pennsylvania and CONRAD's Clinical Research Center at the Eastern Virginia Medical School in Norfolk, Virginia.
The study consisted of a screening visit, a baseline cycle, and up to 2 cycles of post-coital tests (PCTs) for a total of 7 visits. The first PCT was a baseline PCT, performed without the use of any product, in order to demonstrate the subject's ability to produce receptive, midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating the cervical mucus was evaluated in this cycle. Test PCTs were carried out during the second and third menstrual cycle using either the SILCS diaphragm with N-9 or the SILCS diaphragm with lubricant. Cycles were repeated depending on the characteristics of the cervical mucus and the number of sperm found in the vaginal pool and endocervical specimens; thus, some women may undergo more than three PCTs. An additional test cycle with a modified polymer spring device was performed in a subset of participants.
Read more
Colposcopy was performed during the mucus check and post-coital test visits in all three cycles in order to document the baseline condition of the vagina and cervix pre- and post-intercourse and, in test cycles, to note the effect of product.
Vaginal samples were taken from the posterior fornix of the vagina and the cervical os at each visit during the baseline and test cycles to measure for the presence of PSA.
- Conditions
- Contraceptive Device
- Being tested
- SILCS and lubricant, SILCS and spermicide
- Keywords
- Diaphragm, postcoital test, SILCS, nonoxynol-9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILCS and lubricantOther
SILCS and spermicideOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | SILCS with K-Y Jelly Receives: Other: SILCS and lubricant |
| 2 | Active comparator | SILCS with N-9 Receives: Other: SILCS and spermicide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women with any sperm in the cervical mucus, with ≥ 5 progressively motile sperm per high power field (HPF), and the average number of progressively motile sperm per HPF.
Measured: Within 2-3 hours of intercourse.
Secondary outcomes (1)
Symptoms and signs of irritation of the external genitalia, cervix, and vagina before and after intercourse and by gel product. The handling, fit, and general acceptability of the SILCS diaphragm was assessed.
Measured: Before and after intercourse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startAug 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive DeviceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Investigators
- Jill Schwartz, MD, Study director, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561613
- Sponsor's protocol ID
- A02-081
- Status last verified
- Dec 2007
- First submitted
- 19 Nov 2007
- Last updated
- 24 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Schwartz JL, Ballagh SA, Creinin MD, Rountree RW, Kilbourne-Brook M, Mauck CK, Callahan MM. SILCS diaphragm: postcoital testing of a new single-size contraceptive device. Contraception. 2008 Sep;78(3):237-44. doi: 10.1016/j.contraception.2008.04.118. Epub 2008 Jul 3.
PubMed 18692615
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Postcoital Testing and Safety Study of the SILCS Diaphragm, Prototype VI
- ClinicalTrials.gov ID
- NCT00561613
- Acronym / sponsor ID
- A02-081
- Conditions
- Contraceptive Device
- Keywords
- Diaphragm, postcoital test, SILCS, nonoxynol-9
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Aug 2003
- Study completion
- Oct 2004 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase I multi-center, randomized study in 40 healthy, sexually active women not at risk for pregnancy due to previous female sterilization. The male partners of the participants were consented to participate in the study. The clinician evaluating the cervical mucus for midcycle characteristics and presence of sperm was blinded as to gel used. The product tested was the SILCS diaphragm with Gynol II (spermicide) and the SILCS diaphragm with KY Jelly (lubricant). The sequence of diaphragm and gel use was determined by randomization. The study was conducted at two centers, Magee-Womens Hospital in Pittsburgh, Pennsylvania and CONRAD's Clinical Research Center at the Eastern Virginia Medical School in Norfolk, Virginia.
The study consisted of a screening visit, a baseline cycle, and up to 2 cycles of post-coital tests (PCTs) for a total of 7 visits. The first PCT was a baseline PCT, performed without the use of any product, in order to demonstrate the subject's ability to produce receptive, midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating the cervical mucus was evaluated in this cycle. Test PCTs were carried out during the second and third menstrual cycle using either the SILCS diaphragm with N-9 or the SILCS diaphragm with lubricant. Cycles were repeated depending on the characteristics of the cervical mucus and the number of sperm found in the vaginal pool and endocervical specimens; thus, some women may undergo more than three PCTs. An additional test cycle with a modified polymer spring device was performed in a subset of participants.
Colposcopy was performed during the mucus check and post-coital test visits in all three cycles in order to document the baseline condition of the vagina and cervix pre- and post-intercourse and, in test cycles, to note the effect of product.
Vaginal samples were taken from the posterior fornix of the vagina and the cervical os at each visit during the baseline and test cycles to measure for the presence of PSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: SILCS and lubricantSILCS with K-Y Jelly |
| 2 | Active comparator | Other: SILCS and spermicideSILCS with N-9 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Female Participants
- Male Participants
Key exclusion criteria (11 listed)
- Female Participants
- Male Participants
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 |
|---|---|---|
| SILCS and lubricant | Other | 1 |
| SILCS and spermicide | Other | 2 |
Primary outcome
Percentage of women with any sperm in the cervical mucus, with ≥ 5 progressively motile sperm per high power field (HPF), and the average number of progressively motile sperm per HPF.
Time frame: Within 2-3 hours of intercourse.
1 secondary outcome
Symptoms and signs of irritation of the external genitalia, cervix, and vagina before and after intercourse and by gel product. The handling, fit, and general acceptability of the SILCS diaphragm was assessed.
Time frame: Before and after intercourse
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2007.
- Derived from this study: PubMed 18692615Schwartz JL, Ballagh SA, Creinin MD, Rountree RW, Kilbourne-Brook M, Mauck CK, Callahan MM. SILCS diaphragm: postcoital testing of a new single-size contraceptive device. Contraception. 2008 Sep;78(3):237-44. doi: 10.1016/j.contraception.2008.04.118. Epub 2008 Jul 3.
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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.
Jill Schwartz, MD study director
CONRAD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SILCS and lubricant and SILCS and spermicide in people with Contraceptive Device, run by CONRAD at 2 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 17 inclusion and 11 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 24 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of women with any sperm in the cervical mucus, with ≥ 5 progressively motile sperm per high power field (HPF), and the average number of progressively motile sperm per HPF. (time frame: Within 2-3 hours of intercourse.). 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 NCT00561613, 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 24 Dec 2007.