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
Completed · Phase 2
Conditions studied: Ovulation
In brief
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.
Key facts
- Study ID
- NCT00796133
- Run by
- Population Council
- People needed
- 18
- Starts
- 2008-11-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2015-04-17
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Women's and Children's Hospital; LA County/USC Medical Center — Los Angeles, California, United States
- Instituto Chileno de Medicina Reproductiva — Santiago, Chile
- Profamilia — Santo Domingo, Dominican Republic
Full record on ClinicalTrials.gov
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