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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 - NCT00796133-90033(Clinical Trial 254298)



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City:  Los Angeles
State:  
CA
Zip Code: 90033
Conditions: Ovulation
Purpose: 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.
Study summary:
Criteria: 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 hypersensitivity to estrogen - Undiagnosed vaginal discharge or vaginal lesions or abnormalities - In accordance with the Bethesda system of classification Women with a current abnormal Pap smear suggestive of high-grade pre cancerous lesion(s), including HGSIL, are excluded - Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity >CIN I is present and/or endocervical curettage is negative - Women with a biopsy finding of CIN I should have follow up for this finding per standard of care; women are excluded if treatment is indicated In accordance with other Pap class systems - Women with high grade dysplasia are excluded - Women with low grade dysplasia or CIN I interpretation on Pap smear may participate based on investigator discretion in accordance with local standard of care - Breastfeeding - Cancer (past history of any carcinoma or sarcoma) - History of a significant psychiatric disorder, including severe depression. - Chronic or acute liver or renal disease - Hypertension-- controlled by medication or defined by diastolic BP 85 mm Hg or systolic BP 135mm Hg after 15 minutes rest - Dermatitis, psoriasis or other severe skin disorder - Known or suspected alcoholism or drug abuse - Clinically significant abnormalities of laboratory safety tests - Chronic disease or history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject - Woman is participating or has participated in another clinical study (involving an investigational drug) within one month prior to enrollment. - Use of injectable contraceptives during the previous 3 months (e.g. cyclofem) or 9 months (e.g. DMPA) - Use of oral contraceptives within the past 1 month - Use of concomitant drugs that may interact with the study drugs
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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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