Contraception Clinical Trial
Official title:
A Phase I Postcoital Testing Study of the SILCS Diaphragm Used With 3% Nonoxynol-9 Gel, ContraGel, or No Gel
This post coital test study is a Phase I multi-center, randomized, crossover, non-significant risk device study to be carried out at two clinical sites/centers. The products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of product use, with a goal of 10 participants completing the study.
Status | Completed |
Enrollment | 27 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-45 years, inclusive 2. General good health, by volunteer history and per investigator judgment 3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report 4. History of Pap smears and follow-up consistent with standard medical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1 5. Willing to abstain from intercourse and use of vaginal products as required in the protocol 6. Willing to use non-spermicidal, lubricated condoms from the first day of each menstrual cycle until 72 hours before expected midcycle 7. In a mutually monogamous relationship for at least the last four months with a male partner who: 7a. Is at least 18 years old; 7b. Has no known risk for STIs; 7c. Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and 7d. Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol 8. Protected from pregnancy by female tubal sterilization 9. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection 10. Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol Exclusion Criteria: 1. History of hysterectomy 2. Vasectomy in male partner 3. Sterility or known history of sperm dysfunction in male partner 4. Currently pregnant or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome 5. Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera in the last 120 days 6. Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study 7. Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge) 8. Device does not appropriately fit volunteer, as determined by clinician 9. Inability to insert, position, and/or remove study device, by clinician or volunteer 10. History of sensitivity/allergy to 3% N-9, latex, ingredients in ContraGel, or silicone, for either the volunteer or her male partner 11. In the last six months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility 12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis 13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection 14. Positive test for HIV 15. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.) 16. Known current drug or alcohol abuse which could impact study compliance 17. Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study 18. History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days 19. Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Dominican Republic | ProFamilia | Santo Domingo | |
United States | Clinical Research Center, Eastern Virginia Medical School | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
CONRAD |
United States, Dominican Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of women with an average of fewer than 5 progressively motile sperm per high powered field (HPF) as a measure of preliminary effectiveness | Fewer than 5% progressively motile sperm per high power field is considered indicative of acceptable barrier function. Will be calculated separately for each test cycle. | 2-3 hours following coitus | No |
Primary | Per-women average number (across 9 HPFs) of progressively motile sperm per HPF as a measure of preliminary effectiveness. | Mean, median, standard deviation and IQR will be assessed for the baseline cycle and during each test PCT, across all women. Qualitative assessments of change from baseline, if any, will be based on medians and IQRs. | 2-3 hours following coitus | No |
Secondary | Number of treatment emergent adverse experiences among female participants as a measure of safety | Urogenital, product-related, and/or serious AEs will be assessed | Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months | Yes |
Secondary | Number of treatment emergent adverse experiences among male partners as a measure of safety | Urogenital, product-related, and/or serious AEs will be assessed | Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02577601 -
Impact of Combined Hormonal Contraceptives on UPA
|
Phase 4 | |
Completed |
NCT03153644 -
Improving Contraceptive Care for Women With Medical Conditions
|
||
Completed |
NCT04112095 -
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
|
Phase 3 | |
Recruiting |
NCT05521646 -
Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative
|
N/A | |
Active, not recruiting |
NCT04291001 -
Ovarian Function With ENG Implant and UPA Use
|
Early Phase 1 | |
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Completed |
NCT03438682 -
Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
|
||
Active, not recruiting |
NCT01948882 -
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
|
N/A | |
Enrolling by invitation |
NCT04997499 -
Adolescent Subcutaneous (SQ) Injection Video Validation
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03154125 -
Sayana® Press Extension Study
|
Phase 3 | |
Withdrawn |
NCT03725358 -
A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.
|
N/A | |
Completed |
NCT02957630 -
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
|
Phase 1/Phase 2 | |
Completed |
NCT02456584 -
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
|
Phase 1 | |
Completed |
NCT02718222 -
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
|
N/A | |
Recruiting |
NCT02121067 -
LNG-IUS at 2 Weeks Postpartum
|
Phase 4 | |
Terminated |
NCT02169869 -
Immediate Postplacental IUD Insertion
|
N/A | |
Recruiting |
NCT02292056 -
Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
|
N/A | |
Withdrawn |
NCT01930994 -
Kenya Sino-implant (II) PK Study
|
N/A |