Efficacy and safety of a multipurpose vaginal pH-regulator: results from the phase 3, ampower contraception clinical trial
Amphora ® (formerly known as Acidform), a multipurpose vaginal pH-regulator (MVP-R), is a novel, non-hormonal, woman-controlled, on-demand, water-based, petroleum-free vaginal gel being investigated for prevention of pregnancy and sexually transmitted infections. Here we present primary results from the co nfirmatory phase 3 contraception trial, AMPOWER. (Source: Fertility and Sterility)
Source: Fertility and Sterility - August 31, 2019 Category: Reproduction Medicine Authors: Michael A. Thomas, Kelly R. Culwell, Clint Dart, Brandi Howard Tags: Oral session Source Type: research
Women ’s satisfaction with the multipurpose vaginal pH-regulator (MVP-R; Amphora): results from the phase 3 ampower trial
As a multipurpose vaginal pH-regulator, Amphora ® is a novel, non-hormonal, woman-controlled, on-demand, contraceptive vaginal gel being investigated for prevention of pregnancy and sexually transmitted diseases. To better understand the treatment experience from the woman’s perspective, the Satisfaction Questionnaire was administered in the p hase 3 AMPOWER trial (NCT03243305). (Source: Fertility and Sterility)
Source: Fertility and Sterility - August 31, 2019 Category: Reproduction Medicine Authors: Michael A. Thomas, Kelly R. Culwell, Clint Dart, Brandi Howard Tags: Poster session Source Type: research
Combined use of oestradiol and progesterone to support luteal phase in antagonist intracytoplasmic sperm injection cycles of normoresponder women: a case-control study.
In conclusion, our study showed no beneficial effect of addition of E2 to luteal phase support on clinical PR in antagonist IVF cycles. Impact statement What is already known on this subject? Luteal phase deficiency is defined as a disruption in progesterone and oestrogen production after ovulation. It is clear that, luteal phase supplementation to improve the outcomes in in vitro fertilisation (IVF) cycles is mandatory. As an iatrogenic complication of assisted reproductive technique, decreased luteal oestrogen and progesterone levels lead to decreased pregnancy rates (PRs) and implantation rates. What the results of this...
Source: Journal of Obstetrics and Gynaecology - August 30, 2019 Category: OBGYN Tags: J Obstet Gynaecol Source Type: research
Pre-Exposure Prophylaxis for HIV Prevention in Women: Current Status and Future Directions
AbstractPre-exposure prophylaxis (PrEP) is a promising intervention to prevent HIV acquisition, with benefits both to the individual and to population-level health. PrEP is an opportunity to complement ongoing public health efforts to eliminate HIV. For women, PrEP can also serve as a gateway to access sexual and reproductive health (SRH) services. Clinical efficacy of PrEP was initially reported in women using a 1% tenofovir vaginal gel in 2010, followed by an efficacy trial of oral PrEP using TDF/FTC in men who have sex with men (MSM). Since then, further trials have reported efficacy in oral PrEP containing tenofovir in...
Source: Drugs - July 14, 2019 Category: Drugs & Pharmacology Source Type: research
Vaginal Progesterone Gel is Non-inferior to Intramuscular Progesterone in Efficacy with Acceptable Tolerability for Luteal Phase Support: A Prospective, Randomized, Multicenter Study in China
ConclusionsProgesterone gel showed good efficacy and safety outcomes and therefore provides an alternative method of luteal support in Chinese in vitro fertilization patients. (Source: European Journal of Obstetrics and Gynecology and Reproductive Biology)
Source: European Journal of Obstetrics and Gynecology and Reproductive Biology - April 16, 2019 Category: OBGYN Source Type: research
Vaginal Progesterone Gel is Non-inferior to Intramuscular Progesterone in Efficacy with Acceptable Tolerability for Luteal Phase Support: A Prospective, Randomized, Multicenter Study in China
Research suggests the efficacy of progesterone for luteal phase support in assisted reproduction cycles using gonadotropin-releasing hormone analogues. Our study objective was to compare the efficacy of two available preparations of progesterone, vaginal gel and intramuscular injection, for luteal phase support in assisted reproduction cycles. (Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology)
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - April 14, 2019 Category: OBGYN Authors: Hongbin Chi, Rong Li, Jie Qiao, Xiujuan Chen, Xingling Wang, Guimin Hao, Qiongfang Wu, Yunxia Cao, Liyi Cai, Hong Ye, Yimin Zhu, Shuyu Wang, Xuehong Zhang, Cuilian Zhang, Yunshan Zhang, Qun Lv, Yingpu Sun, Hong Li, Xuefeng Huang, Fang Wang Tags: Full length article Source Type: research
Transvaginal Natural Orifice Transluminal Endoscopic Hysterectomy and Apical Suspension of the Vaginal Cuff to the Utero-Sacral Ligament
CONCLUSIONSTransvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) to repair of POP by utero-sacral ligament suspension via a vaginal port is a feasible technique with promising cosmetic results. This technique allows surgeon to expose the ureter well and lower the risk of ureteric injury. additionally, this approach avoids mesh complications and should also decrease the risk of abdominal wound infection because of the absence of incisions on the abdomen. (Source: Journal of Minimally Invasive Gynecology)
Source: Journal of Minimally Invasive Gynecology - April 11, 2019 Category: OBGYN Source Type: research
Chinese Herbal Formula Feilin Vaginal Gel Prevents the Cervicitis in Mouse Model.
Authors: Mao X, Zhao R, Yao R, Guo S, Bao L, Gao Y, Sun J, Bao Y, Shi Y, Cui X
Abstract
Cervicitis is a common sexually transmitted disease. In recent years, the abuse of antibiotic in the treatment of cervicitis results in the emergence of antibiotic-resistant bacteria; alternative strategies are needed to be developed. In this research, we investigated the effects of Feilin Vaginal Gel (FVG), a Chinese herbal formula, on the treatment of cervicitis. Two cervicitis models were optimized using BALB/c mouse; one in vitro model was established in HeLa cells. In Chlamydia trachomatis-induced cervicitis model,...
Source: Evidence-based Complementary and Alternative Medicine - February 9, 2019 Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Understanding women ’s motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence
In biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral ta... (Source: BMC Women's Health)
Source: BMC Women's Health - January 25, 2019 Category: OBGYN Authors: Ariana W. K. Katz, Barbara S. Mensch, Kubashni Woeber, Petina Musara, Juliane Etima and Ariane van der Straten Tags: Research article Source Type: research
Effect of Hormonal Contraception on Pharmacokinetics of Vaginal Tenofovir in Healthy Women: Increased Tenofovir Diphosphate in Injectable Depot Medroxyprogesterone Acetate Users
We present PK data from healthy women using tenofovir vaginal gel, at baseline (follicular and luteal phases) and after oral contraceptive pill (OCP) or depot medroxyprogesterone acetate (DMPA) use.
Methods:
CONRAD A10-114 was a prospective, interventional, open-label, parallel study. We enrolled 74 women and 60 completed the study (32 and 28 who selected OCPs or DMPA, respectively). Participants used 2 doses of tenofovir gel separated by 2 hours, without intercourse, and were examined 3 or 11 hours after the last dose. We assessed pharmacokinetics in plasma, cervicovaginal (CV) aspirate, and vaginal tissue.
Results:
...
Source: JAIDS Journal of Acquired Immune Deficiency Syndromes - December 11, 2018 Category: Infectious Diseases Tags: Clinical Science Source Type: research
Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization
To assess patient experience and convenience of using progesterone vaginal ring (VR) versus vaginal gel for women requiring luteal phase support during in vitro fertilization (IVF). (Source: Fertility and Sterility)
Source: Fertility and Sterility - November 1, 2018 Category: Reproduction Medicine Authors: Elizabeth S. Ginsburg, Teru Jellerette-Nolan, Gaurang Daftary, Yunling Du, Kaylen M. Silverberg Tags: Original article Source Type: research
Post hoc analysis of a randomized placebo-controlled pilot study on the effect of Amphora ®, an acid-buffering vaginal gel, on vaginal pH by baseline vaginal pH level
The objective of this study was to determine the change and duration of change in vaginal pH with intravaginal administration of single doses of an acid-buffering gel (Amphora) by baseline vaginal pH level. (Source: Fertility and Sterility)
Source: Fertility and Sterility - September 1, 2018 Category: Reproduction Medicine Authors: J. Griffiss, A. Avery, S. Nayak, D.R. Friend, K.R. Culwell Tags: Oral session Source Type: research
Product acceptability and assessment of genitourinary discomfort in a phase 3 trial comparing an acid-buffering contraceptive vaginal gel (amphora ®) to nonoxynol-9
To present data on product acceptability and genitourinary discomfort when using Amphora ®, an investigational acid-buffering contraceptive vaginal gel, vs. nonoxynol-9 (Conceptrol®). (Source: Fertility and Sterility)
Source: Fertility and Sterility - September 1, 2018 Category: Reproduction Medicine Authors: E. Andruczyk, K.R. Culwell, B. Howard Tags: Oral session Source Type: research
An overview of properties of Amphora (Acidform) contraceptive vaginal gel.
Authors: Nelson AL
Abstract
INTRODUCTION: Although only a minority of contracepting women rely solely on spermicides, they are the only ongoing female method available without a prescription in the United States. Spermicides are also combined with other methods for additional pregnancy protection and/or lubrication. Nonoxynol-9 (N-9), the active ingredient in most spermicides, is cytotoxic and may increase risk of HIV and other sexually transmitted infections, especially in high risk women. Amphora (previously called Acidform) is a non-cytotoxic spermicide composed of a series of GRAS compounds, which main...
Source: Expert Opinion on Drug Safety - August 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research
FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir.
CONCLUSIONS: Films were safe and well tolerated. Furthermore, films delivered TFV to mucosal tissues at concentrations similar to gel and were sufficient to block HIV infection of genital tissue ex vivo.
PMID: 30101439 [PubMed - in process] (Source: Journal of the International AIDS Society)
Source: Journal of the International AIDS Society - August 15, 2018 Category: Infectious Diseases Tags: J Int AIDS Soc Source Type: research
