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NCT ID: NCT01432470 Completed - Postmenopause Clinical Trials

Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women

Start date: August 2010
Phase: Phase 2
Study type: Interventional

Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning, itching or discomfort, which often make sex to become difficult or painful. These symptoms combined are known as vaginal atrophy. Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier, and less elastic due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections. The mucosal epithelium shows signs of severe atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells. Estrogen treatment either as hormone replacement therapy or topical application is a common treatment for vaginal atrophy. However, some women experience adverse reactions such as uterine bleeding, perineal pain and breast pain and many women are also reluctant to use estrogens due to a general negative view to this topic in the society. Oxytocin is a peptide hormone, which is normally released into the circulation via the pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. In addition, oxytocin has in vitro been shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women. Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation, topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal atrophy. In one previous placebo-controlled study on 20 postmenopausal women suffering from vaginal atrophy, a gel containing oxytocin for topical intra-vaginal administration was applied daily for seven days. The results indicated that for subjects receiving topical oxytocin the vaginal atrophy assessed by histological examination was reversed after treatment. A similar effect was not seen in the placebo group, which indicated a difference between placebo and active treatment. However, the limited number of exposed subjects in this pilot study necessitates a larger study in order to generate conclusive proof of concept data for the effects of oxytocin on vaginal atrophy. Due to the limitations of estrogens in the treatment of vaginal atrophy, many postmenopausal women are left without an effective remedy. Hence, there is a need for alternative non-estrogenic treatments of this indication. The present study is aiming to investigate the efficacy of topical oxytocin in the treatment of vaginal atrophy. The main objective of this study is to investigate if topical oxytocin can reverse vaginal atrophy, as assessed by cytological examination of the vaginal mucosal epithelium, in postmenopausal women after 12 weeks of treatment as compared to placebo.

NCT ID: NCT01432379 Completed - Migraine Disorders Clinical Trials

BOTOX® Prophylaxis in Patients With Chronic Migraine

Start date: September 9, 2011
Phase:
Study type: Observational

This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.

NCT ID: NCT01431755 Completed - Clinical trials for Facial Tissue Augmentation

A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride

Start date: September 2011
Phase: N/A
Study type: Interventional

The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.

NCT ID: NCT01431287 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

Start date: September 2011
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.

NCT ID: NCT01430936 Completed - Clinical trials for Cardiac Decompensation

Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices

REMOTE-HF-1
Start date: January 2011
Phase: N/A
Study type: Observational

This is planned as a feasibility study. The objective is to evaluate a specially designed patient adherence and monitoring software on standard mobile devices in remote monitoring of heart failure patients.

NCT ID: NCT01430546 Completed - Multiple Myeloma Clinical Trials

Non-interventional Study on Time to Response and Quality of Life in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide in Second Line

Start date: November 2010
Phase: N/A
Study type: Observational

The purpose of this study is to quantify the burden of treatment in relapsed or refractory multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.

NCT ID: NCT01430494 Completed - Clinical trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

OVERTURE
Start date: June 2011
Phase: N/A
Study type: Observational

To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

NCT ID: NCT01428947 Completed - Clinical trials for Coronary Heart Disease

Does Coronary Angiography Cause Cognitive Dysfunction?

Start date: September 2011
Phase: N/A
Study type: Observational

The purpose of the study is to study if coronary angiography cause cognitive dysfunction.

NCT ID: NCT01428453 Completed - Alzheimer's Disease Clinical Trials

A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease

Start date: October 1, 2011
Phase: Phase 2
Study type: Interventional

The study is designed to investigate the effects of rilapladib on biomarkers related to the Alzheimer's disease, and cognitive function.

NCT ID: NCT01428206 Completed - End-of-life Care Clinical Trials

Liverpool Care Pathway for the Dying at Residential Care Homes

Start date: June 2009
Phase: N/A
Study type: Interventional

Liverpool Care Pathway for the dying patient (LCP) was developed to transfer the care practice from the hospice setting to the hospital setting in UK. LCP is a pathway with standardized registration method to monitor the care and its results. The primary aim is to study the effects of LCP on dying patients symptom burden and communication with close relatives and health care professionals.