No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 40
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
15 (estimated)
Sponsor
Oregon Health and Science University · Other
Who this trial is looking for
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Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral gonadotropin-releasing hormone antagonist (gnRH). Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Normal menstrual cycles of 25-35 days in length for at least the previous 3 cycles
* BMI \>18 and \<35
* Serum p4 \>= 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle
* Flexible schedule allowing blood draws on less than 48 hour notice
* I…
Inclusion Criteria:
* Normal menstrual cycles of 25-35 days in length for at least the previous 3 cycles
* BMI \>18 and \<35
* Serum p4 \>= 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle
* Flexible schedule allowing blood draws on less than 48 hour notice
* In good general health
* Commit to using non-hormonal contraceptive methods without spermicide during study period except those prescribed in the experimental protocol
* No objections to taking study drugs
* No objections to refraining from intercourse the night before any sampling and willing to use condoms during vaginal intercourse
Exclusion Criteria:
* Oral contraceptive use or other hormone supplement within the preceding 2 months
* Current cervical infection
* Evidence of abnormal cervical cytology
* Use of any IUD for contraception
* Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera)
* Contraindications to study drugs
* Current or past pregnancy within the previous 6 months or currently trying to conceive
* Desiring to conceive in the next 8 months
* Breastfeeding in the past 2 months
* Diagnosed diabetes or metabolic syndrome
* Diagnosed Polycystic Ovary Syndrome
* History of, or self-reported, substance abuse
* Smoker
* Previous infertility treatment excluding male factor issues
* Use of an investigational drug within the past 2 months
* History of excisional or ablative treatment procedure on cervix (i.e., LEEP, Cryotherapy, Cold Knife Cone)
* Current treatment for a vaginal infection such as bacterial vaginosis
* History of venous thromboembolism (VTE) or inherited thrombophilias
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