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New treatment option for Contraception
Official title Endometrial Biopsy in Progestin Contraceptive Users
ClinicalTrials.gov ID: NCT05760144
What this study is testing
What is DMPA?
DMPA is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for contraception.
Also referred to as Depo-Provera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to learn more about menstrual changes in progestin contraception users. The investigators are hoping to find out what changes in the endometrium lead to different bleeding patterns during the first year of progestin contraception use.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
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
- 18-4 0 years of age at time of enrollment in good general health
- Regular menstrual cycles (25-35 day cycle length with bleeding 8 days or less)
- Body Mass Index of 19-35
- Confirmed ovulation with a screening serum progesterone of greater than 3ng/mL
- No contraindications to DMPA or hormonal implant
You likely can't join if
- Hormonal or intrauterine contraceptives or other hormone use prior to start of study enrollment [No oral hormonal contraceptives or other hormones...
- Any known uterine pathology (endometriosis, leiomyoma or adenomyosis; bacterial, fungal or viral infection, active cervicitis). For bacterial...
- Positive gonorrhea/chlamydia screening performed at screening visit, unless treated as noted above.
- Routine or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs once daily or more 14 or more days per month)
- Abnormal uterine bleeding
- Polycystic ovary syndrome
See the full eligibility criteria
- 18-4 0 years of age at time of enrollment in good general health
- Regular menstrual cycles (25-35 day cycle length with bleeding 8 days or less)
- Body Mass Index of 19-35
- Confirmed ovulation with a screening serum progesterone of greater than 3ng/mL
- No contraindications to DMPA or hormonal implant
- Hormonal or intrauterine contraceptives or other hormone use prior to start of study enrollment [No oral hormonal contraceptives or other hormones for at least one month, no implantable contraceptives or hormonal or...
- Any known uterine pathology (endometriosis, leiomyoma or adenomyosis; bacterial, fungal or viral infection, active cervicitis). For bacterial infection such as gonorrhea (GC) /chlamydia (CT) enrollment should be delayed...
- Positive gonorrhea/chlamydia screening performed at screening visit, unless treated as noted above.
- Routine or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs once daily or more 14 or more days per month)
- Abnormal uterine bleeding
- Polycystic ovary syndrome
- Currently pregnant or planning pregnancy during the study
- Less than 6 month postpartum or breastfeeding, post abortion 6 weeks, not breast/chest feeding (cessation 4-6 weeks from enrollment)
- Centers for Disease Control Medical Eligibility for Contraceptive use category 3 or 4 for contraceptive usage (Current or prior medical history of thrombosis or thromboembolic disorders, Liver tumors or active liver...
- Anticoagulation use
- Bleeding dyscrasia
- Use of P450 pathway inducing drug(s)
- Inability to tolerate uterine sounding (at screening visit)
- Chronic use of Cannabidiol, THC, or marijuana (More than 3 times per week). Of note, patients could have used Cannabidiol, THC, or marijuana chronically in past, but must have a washout time period of no use for at...
- Chronic use of cigarettes (More than 1 cigarette per week). Of note, patients could have used cigarettes chronically in past, but must have a washout time period of no use for at least six months prior to the study.
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
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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.