Archive for month: May, 2024

In a small early-phase study published in Contraception Journal, the investigational hormone-free contraceptive device left in place for 21 days, showed preliminary evidence of contraceptive efficacy. Ovaprene use resulted in meeting the prespecified criterion for contraceptive effect by all participants during all postcoital test cycles.

“The finding that Ovaprene use resulted in postcoital testing of cervical mucus that met the pre-specified definition of success (<5 progressively motile sperm/HPF) supports further assessment of device’s contraceptive efficacy in users at risk for pregnancy,” the researchers wrote. There were no reports of cervicovaginal irritation or adverse effects on normal vaginal bacteria.

Unlike traditional hormonal contraceptives, which can sometimes cause adverse side effects such as weight gain, mood swings, and changes in libido, Ovaprene, an investigational monthly non-hormonal vaginal contraceptive consisting of a vaginal ring and mechanical barrier, releasing spermiostatic ferrous gluconate, offers a hormone-free alternative. This makes it particularly appealing to women who may prefer non-hormonal methods or who experience intolerance to hormonal contraceptives.

Against the above background, Christine Mauck, Daré Bioscience, Inc., San Diego, CA, United States, and colleagues aimed to evaluate the reduction in progressively motile sperm per high power field (HPF) in midcycle cervical mucus after intercourse with Ovaprene.

For this purpose, the researchers conducted an open-label, multicenter study enrolling heterosexually-active women with previous permanent contraception.

Participants underwent a baseline postcoital test cycle with no device to confirm sperm presence, followed by one diaphragm postcoital test cycle, one Ovaprene safety cycle, and two Ovaprene postcoital test cycles.

In each postcoital test cycle, participants underwent a midcycle cervical mucus evaluation to confirm an Insler score ≥10 and the absence of sperm. Then they returned two to four hours after vaginal intercourse for repeat cervical mucus evaluation. The researchers considered <5 progressively motile sperm/HPF indicative of preliminary contraceptive effectiveness.

The following were the key findings of the study:

· 38 participants were enrolled; 23 completed the study.

· All participants had ≥5 progressively motile sperm/HPF in the baseline cycle and <5 progressively motile sperm/HPF in all 49 Ovaprene cycles and all 35 diaphragm cycles, meeting the definition of a successful postcoital test. This was true regardless of examiner blinding, body mass index, prior vaginal delivery or vaginal ring use, or dislodgements noted by the participant or investigator.

· The mean of 27.2 progressively motile sperm/HPF in baseline postcoital test cycles was reduced to 0.5 and 0.5 progressively motile sperm/HPF in the first and second Ovaprene cycles, respectively.

· Ovaprene fit all participants, and all could insert, position, and remove it.

The findings showed that ovaprene fit all participants, and all were able to insert, position, and remove it, in most cases using only written instructions. The device was revealed to be over the cervix at almost every examination.

Postcoital test cycles were successful even when the device was out of place, probably indicating the spermiostatic effect of ferrous gluconate.

As discussions surrounding reproductive rights and contraceptive options continue to evolve, innovations like Ovaprene offer renewed hope for expanding choices and meeting the diverse needs of women worldwide.

“A pivotal study is underway in which participants at risk of pregnancy will use the device for 13 cycles, and actual contraceptive effectiveness will be assessed,” the researchers wrote.

Reference:

Mauck, C., Thurman, A., Jensen, J. T., Schreiber, C. A., Baker, J., Hou, M. Y., Chavoustie, S., Dart, C., Wu, H., Zack, N., Hatheway, J., & Friend, D. (2024). Successful postcoital testing of Ovaprene: An investigational non-hormonal monthly vaginal contraceptive. Contraception, 132, 110373. https://doi.org/10.1016/j.contraception.2024.110373

The dietary acid load is determined by the balance of acid-inducing foods, such as eggs, meats, cheese and cereal grains, and base-inducing foods, such as vegetables and fruits. 

Previous studies have revealed an association between chronic metabolic acidosis and cardiometabolic risk factors. Mohammad Alizadeh, Tabriz University of Medical Sciences, Tabriz, Iran, and colleagues aimed to explore the association between Potential Renal Acid Load (PRAL) and Net Endogenous Acid Production (NEAP) with these risk factors in an updated meta-analysis.

For this purpose, the researchers searched the online databases up to May 2023. The mean of body mass index (BMI), waist circumference (WC), high- and low-density lipoprotein-cholesterol (HDL-C and LDL-C), triglyceride, fasting blood sugar (FBS), total cholesterol (TC), and systolic- and diastolic blood pressure (SBP and DBP) in highest category versus lowest categories of NEAP and PRAL were recorded. Effect sizes were generated as weighted mean difference (WMD).

The researchers reported the following findings:

• Low PRAL and NEAP scores are significantly related to lower systolic BP and diastolic BP.
• Lower PRAL and NEAP scores are significantly associated with lower waist circumference values.
• The lowest versus highest categories of PRAL were associated with lower body mass index.
• There was a significant association between low serum triglyceride and low PRAL score.

“Findings showed that SBP, DBP, and WC had a significant difference in the upper and lower categories of PRAL (WMDSBP: -1.466 mmHg, WMDDBP: -0.710 mmHg, and WMDWC: -0.819 cm) or NEAP (WMDSBP: -1.690 mmHg, WMDDBP: -1.076 mmHg, and WMDWC: -1.325 cm),” the researchers reported.

“The lowest versus highest categories of dietary PRAL were associated with lower BMI (WMDPRAL: -0.297 kg/m2) and TG (WMD: -2.280 mg/dl).”

“High dietary acid load can be considered as an independent risk factor for increasing blood pressure, anthropometric indices, and TG,” they concluded.

Reference:

Dolati, S., Razmjouei, S., Faghfouri, A. H., Moridpour, A. H., & Alizadeh, M. (2024). A high dietary acid load can potentially exacerbate cardiometabolic risk factors: An updated systematic review and meta-analysis of observational studies. Nutrition, Metabolism and Cardiovascular Diseases. https://doi.org/10.1016/j.numecd.2024.01.013

The parties have entered into a long-term agreement to develop mRNA vaccines against a broad range of infectious diseases, in India and several other countries. As part of their agreement, HDT has granted a license to Gennova to use HDT’s patented mRNA vaccine technology in multiple fields.

“EMCURE is delighted that the misunderstanding between us and HDT not only stands resolved but we have widened the scope of our technical collaboration on a long term basis. mRNA platform will be the launching pad for our foray into vaccines for tuberculosis, rabies, dengue and other infectious diseases and our collaboration with HDT will be mutually beneficial,” observed Satish Mehta, CEO & Managing Director of EMCURE.

CEO of HDT, Dr Steve Reed, echoed Mehta’s sentiments and added that “HDT’s proprietary technology, combined with Emcure’s & Gennova’s innovation and manufacturing excellence and established distribution network will bring life-saving vaccines to countless people. We are committed to a successful relationship with Emcure and Gennova.”

Established in 1981, Emcure Pharmaceuticals Ltd. (EPL) is an Indian pharmaceutical company headquartered in Pune engaged in developing, manufacturing and globally marketing a broad range of pharmaceutical products across several major therapeutic areas. Emcure is present in 70+ countries globally including Europe and Canada. 

Read also: Sanofi India, Emcure Pharma forge exclusive partnership for cardiovascular product distribution