Phase I/II clinical safety studies of terameprocol vaginal ointment

Khanna, Niharika; Dalby, Richard N.; Tan, Ming; Arnold, Sarah Louise; Stern, Jennifer; Frazer, N.

doi:10.1016/j.ygyno.2007.08.074

Cited by 52 publications

(27 citation statements)

References 28 publications

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“…It was found that terameprocol formulated at 1% and 2% (w/w) in a white petrolatum ointment for vaginal administration was safe and well tolerated by healthy women enrolled in a clinical safety study (68,69). Expanded safety and efficacy studies have been planned.…”

Section: Semisolids-ointmentmentioning

confidence: 99%

Vaginal Drug Delivery Systems for HIV Prevention

Rohan

Sassi

2009

AAPS J

140

130

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Abstract. Microbicides have become a principal focus for HIV prevention strategies. The successful design of drug delivery systems for vaginal microbicide drug candidates brings with it a multitude of challenges. It is imperative that the chemical and physical characteristics of the drug candidate and its mechanism of action be clearly understood and considered to successfully deliver and target drug candidates efficiently. In addition, an understanding of the dynamic nature of the vaginal environment, the tissue and innate barriers present, as well as patient preferences are critical considerations in the design of effective microbicide products. Although the majority of drug candidates clinically evaluated to date have been delivered using conventional semisolid aqueous-based gel dosage forms, drug delivery system design has recently been extended to include advanced delivery systems such as vaginal rings, quick-dissolve films, and tablets. Ultimately, it may be necessary to develop multiple dosage platforms for a single active agent to provide users with options that can be used within the constraints of their social environment, personal choice, and environmental conditions.

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Section: Semisolids-ointmentmentioning

confidence: 99%

Vaginal Drug Delivery Systems for HIV Prevention

Rohan

Sassi

2009

AAPS J

140

130

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“…Although alternatives to excisional biopsy or cervical ablation are in early-phase therapeutic clinical trials (eg, terameprocol used topically for CIN), they are not standard of care. 11 Further, utilization of excisional biopsy is standard of care in cases of CIN II and/or III in adult women unless there are clear parameters that contradict the use of loop electrosurgical excision procedure (LEEP).…”

Section: Management Of Cinmentioning

confidence: 99%

Treating Cervical Dysplasia: Why Does It Matter?

Khanna

2010

The Journal of the American Board of Family Medicine

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The cone biopsy described in the case series discussed by Mulhem et al 1 touches on several key issues in cervical cancer prevention and within the scope of practice of family physicians. In the current medical environment health care reform to bolster primary care to reduce health care costs are being proposed; such internal discussions within the family medicine community are timely and germane to reform.2-5 The role of family medicine specialists in implementing and translating technological advances in science into clinical practice is undervalued and unappreciated within the medical system hierarchy. 6 There is a need for family physicians to lead the way in adopting and implementing such new technologies into clinical practice and generating implementation, service, and patientrelated outcomes data, which evidence rigorous evaluation within real-world settings. The Big PictureIn the United States and other developed countries, cervical cancer prevention with organized screening programs is actively taking new shape. Since the 1950s and the widespread use of Papanicolaou smear screening there has been a decline in the number of cervical cancers in the United States, with 11,070 invasive cervical cancers detected in 2008 and 4,070 deaths. 7 Concurrent to the decrease in cervical cancer is an observed increase in the detection of cervical precancer or cervical intraepithelial neoplasia (CIN). Screening practices using cytology and human papillomavirus (HPV) typing has lead to the detection of an estimated 20 million women in the United States who are already infected with HPV and 1.875 million women infected with CIN per year. In addition, Papanicolaou smear detects 2 million women with atypical squamous cells of unknown significance. 8 This process has lead to large numbers of women who are seen within family practices nationwide who need intervention after being diagnosed with a non-lifethreatening precancer. HPV VaccineThe prophylactic L1 subunit HPV vaccine is one of the technological advance of this century. However, administration of the vaccine and its implementation into clinical practice has been poorly accepted, particularly among target populations including minority women with a high prevalence of HPV infection. The true potential of this vaccine has not been realized because of imperfect penetration within the community and subpar vaccination of the US population.9 Assuming that translational science in clinical implementation accrues in HPV vaccine delivery, leading to significant increases in populations that have been vaccinated against HPV, there still are expected to be millions of US women who are already infected with the HPV and thus at risk for CIN. In addition, the vaccine contains 2 of the many HPV subtypes that cause dysplasia and cancer, leaving women unprotected against other HPV strains that account for 30% of cervical disease. Thus, in the foreseeable future there will be a need to refine the management of CIN within primary care and will require judicious consultation with our ...

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“…These are discussed below in more detail, However, it should be clarified that specific types of dosage forms (as 800 in-situ forming hydrogels) may be initially administered as liquids before 801 they are transformed to semisolids (by increase in their viscosity), due to 802 a specific physiological trigger (as pH or temperature). ointments [173] and were found to be safe and well-tolerated [72,174]. leakage [83], and in another study women reported that the leakage of 865 the product would prevent them from using it again [186].…”

mentioning

confidence: 99%