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Tests treatment safety and results for Contraception
Official title Contraceptive Efficacy Study of Ovaprene
ClinicalTrials.gov ID: NCT06127199
What this study is testing
- What it's testing
- This will be a multi-center, single arm, open-label study of Ovaprene, a non-hormonal intravaginal ring, to investigate the contraceptive effectiveness, safety and acceptability of Ovaprene.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception.
- General good health, by subject history and per investigator judgement
- Age 18 through 40 years, inclusive; approximately 66 people \>35 years old at visit 2 will be the Enrolled-Eligible Population
- In a relationship with a person assigned male at birth who meets eligibility criteria below. --At least 18 years old, not known to be subfertile or...
- Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days, without heave bleeding that lasts longer...
You likely can't join if
- Currently pregnant and/or have a positive urine pregnancy test at screening.
- Have an allergy to the ingredients in Ovaprene
- Have a history of toxic shock syndrome
- Have a history of hereditary hemochromatosis
- Be breastfeeding an infant
- Have a history suggestive of infertility, defined as any of the following: known history of ectopic pregnancy or other fertility problem...
See the full eligibility criteria
Who can join
- Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception.
- General good health, by subject history and per investigator judgement
- Age 18 through 40 years, inclusive; approximately 66 people \>35 years old at visit 2 will be the Enrolled-Eligible Population
- In a relationship with a person assigned male at birth who meets eligibility criteria below. --At least 18 years old, not known to be subfertile or infertile
- Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days, without heave bleeding that lasts longer than 5 days
- Be willing to stop their current method of contraception (with the exception of condoms) before Visit 2. Participants must experience at least one subsequent menstrual bleed before inserting Ovaprene. Participants using...
- Not be actively desiring pregnancy for at least 13 months and be willing to accept an unknown risk of pregnancy
- Expect to engage in at least 4 acts of heterosexual vaginal intercourse per cycle during the study.
- Be willing to only use Ovaprene as the sole method of contraception over the course of the study
- Agree not to participate in any other clinical trials during the course of the study
- Be willing and able to comply with study procedures and to return to the clinic for scheduled follow-up visits
- Microbiota/innate immunity and colposcopy subsets only:
- Be willing to avoid vaginal sex and using tampons and other intravaginal products for 48 hours prior to clinic visits; and be willing to comply with subset procedures
What rules you out
- Currently pregnant and/or have a positive urine pregnancy test at screening.
- Have an allergy to the ingredients in Ovaprene
- Have a history of toxic shock syndrome
- Have a history of hereditary hemochromatosis
- Be breastfeeding an infant
- Have a history suggestive of infertility, defined as any of the following: known history of ectopic pregnancy or other fertility problem; sterilization/permanent contraception; endometriosis or hospitalization for...
- Currently have postcoital bleeding
- Have contraindications to pregnancy (medical condition) or chronic use of medications contraindicated in pregnancy
- Have a history of clinically significant uterine prolapse, cystocele, or rectocele that has required surgical intervention or pessary use
- Positive human immunodeficiency virus (HIV) test at screening
- Have exclusionary results on human papilloma virus (HPV) screening/cytology (people\>/=21 years old) at screening or require treatment or follow-up for an abnormal Pap smear or HPV test that would be needed during the...
- Have had a vaginal or cervical biopsy within 1 month or vaginal surgery within the 3 months prior to screening
- Known current drug or alcohol abuse which, in the opinion of the investigator, could impact study compliance
- Have previously been included in the Enrolled-Eligible Population
- Is a direct employee or immediate family member of the Sponsor company, site Investigators or study staff
- Have taken any investigational drug or used any investigational device within the 30 days prior to screening
- Have a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could...
- Microbiota/innate immunity subset only: --systemic use in the last 2 weeks prior to screening or anticipated use during the study of antibiotics (other than those used to treat urinary tract infection (UTI)...
- If male partner has or is suspected to have had an HIV infection or other sexually transmitted infection
- if male partner has a known sensitivity or allergy to the ingredients in Ovaprene
- If male partner has previously participated in this study or has taken any investigational drug or used any investigational device within 30 days prior to the female subject's screening
- If the male partner has a history of any severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or could interfere with the interpretation of trial...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Berkeley, California, United States
- Los Angeles, California, United States
- Newhall, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Honolulu, Hawaii, United States
- Marrero, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Newark, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Berkeley, California, United States; Los Angeles, California, United States; Newhall, California, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.