A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Deli… (NCT00796133) | Clinical Trial Compass
CompletedPhase 2
A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women
United States, Chile, Dominican Republic18 participantsStarted 2008-11
Plain-language summary
This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Woman is between 18 and 40 years of age
* Has intact uterus and ovaries
* Has regular menstrual cycles of 25-35 days duration
* Able to comply with the protocol, including frequent blood sampling, and lives within the catchment area of the clinic
* Understands the study procedures and agrees to participate in the study by giving written informed consent
* Able to use non-hormonal, double-barrier contraceptives (e.g. condoms and diaphragm) with every act of intercourse, or has been sterilized with tubal ligation, or only male partner has been sterilized with vasectomy
* Progesterone \>10 nmol/L in at least one sample in the lead-in cycle
Exclusion Criteria:
* All contraindications to OC use including
* Thrombophlebitis or thromboembolic disorders
* Past history of deep vein thrombophlebitis or thromboembolic disorders
* Past or current cerebrovascular or coronary artery disease
* Known or suspected carcinoma of the breast
* Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
* Undiagnosed abnormal genital bleeding
* Cholestatic jaundice of pregnancy or jaundice with prior pill use
* Hepatic adenomas or carcinomas
* Woman has a history of headaches with focal neurological symptoms
* Known or suspected pregnancy
* Aged \>35 and smoker
* BMI \>29
* Positive urine pregnancy test at the screening or baseline visit
* Desired pregnancy within the duration of the study
* Known hypersensitivity to progestins
* Known hypersensit…
What they're measuring
1
Determine with ultrasound scan (USS) measures and serum progesterone (P) assessment the lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles
Timeframe: Subjects will remain in the study for approximately 8 months