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NCT ID: NCT03230539 Recruiting - Contraception Clinical Trials

A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA)

Start date: May 1, 2017
Phase: Phase 1
Study type: Interventional

The UPA doses to be tested in this new IUS, 5, 20 or 40 μg per day, are not expected to suppress ovulation, however they should prevent endometrial growth resulting in endometrial atrophy, minimal bleeding, or even amenorrhea. It is anticipated that with low UPA doses, women will continue to ovulate and secrete progesterone (P) during the secretory phase of the menstrual cycle. As a result, PRM associated endometrial changes (PAECs) that have been described in previous UPA studies when ovulation was suppressed and associated with amenorrhea should not occur and endometria should retain normalcy. These expectations are based on our findings from a previous study in which the UPA doses tested were insufficient to block ovulation and participants maintained P secretion with normal endometria (protocol 349). Further evidence regarding the benefit of using low doses of UPA in a copper IUS stems from a small rhesus macaque proof of principle study that included an UPA-IUS delivering 40 or 60 μg/d of UPA, and fixed doses of E2 and cyclic P delivered via implants over 3 cycles.24 Indices of endometrial proliferation were significantly reduced in 3 out of 5 animals in that study; the endometria were atrophied with some glandular cysts, and typical PAECs were limited. Glands were generally small and tubular, however, in some animals they were large and dilated; resembling cysts with minimal evidence of proliferative activity.24 No bleeding was observed in the treated monkeys during progesterone withdrawal over the 3 cycles.

NCT ID: NCT03229421 Enrolling by invitation - Clinical trials for Zika Virus Symptoms and the Associated Exanthema

Dermatologic Manifestations of Zika Virus

Start date: July 6, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.

NCT ID: NCT03199235 Recruiting - Anemia Clinical Trials

Iron Fish in Dominican Republic (DR) Children

Start date: February 20, 2017
Phase: N/A
Study type: Interventional

The objective of the study is to assess the acceptability, feasibility, and barriers to Lucky Iron Fish™ (LIF) utilization among families with young children in a Latin American community with a high prevalence of iron deficiency and iron-deficiency anemia.

NCT ID: NCT03154125 Recruiting - Contraception Clinical Trials

Sayana® Press Extension Study

Start date: September 22, 2017
Phase: Phase 3
Study type: Interventional

This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use.

NCT ID: NCT03107611 Completed - Atopic Dermatitis Clinical Trials

Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

Start date: February 29, 2016
Phase: Phase 3
Study type: Interventional

To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis. To establish superiority of each active treatment over the placebo.

NCT ID: NCT03021499 Recruiting - Lupus Nephritis Clinical Trials

Aurinia Renal Response in Active Lupus With Voclosporin

Start date: May 17, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

NCT ID: NCT03005964 Completed - Plaque Psoriasis Clinical Trials

Safety and Efficacy Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis

Start date: December 2016
Phase: Phase 2
Study type: Interventional

To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of plaque psoriasis

NCT ID: NCT02943070 Active, not recruiting - Clinical trials for Benign Prostatic Hyperplasia

Rezum I Pilot Study for BPH

Rezum Pilot
Start date: March 2012
Phase: N/A
Study type: Interventional

Evaluate the safety and efficacy of the Rezum System for the treatment of BPH

NCT ID: NCT02940392 Active, not recruiting - Clinical trials for Benign Prostatic Hyperplasia

Rezum FIM Optimization

Rezum FIM
Start date: February 2012
Phase: N/A
Study type: Interventional

Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).

NCT ID: NCT02904369 Recruiting - HIV Clinical Trials

PK and PD Study of Oral F/TAF for HIV Prevention

Start date: October 2016
Phase: Phase 1
Study type: Interventional

This multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral tablets to assess systemic and genital tract bioavailability in healthy women. The oral tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300 mg, Truvada). Samples will be obtained before, during and after dosing in two study phases.