Milprosa (progesterone vaginal ring) / Ferring - LARVOL DELTA

Measuring potential interest in a postpartum contraceptive vaginal ring among breastfeeding women in India. (PubMed, PLOS Glob Public Health) - "In this paper, we estimate the potential market size in India for the progesterone vaginal ring (PVR), a novel user-controlled contraceptive method that offers additional contraceptive choice for lactating women...We estimate the potential market size for the PVR ranges from a low estimate of 543,262 women to a high estimate of 1.3 million women, with a separate intermediate estimate of 737,460 women. Our analysis indicates the PVR could play an important role in decreasing unmet need among postpartum women in India, thereby reducing risks to mothers and children associated with short birth intervals, helping to prevent unintended pregnancies, and helping to address access-related issues heightened by the COVID-19 pandemic."

Journal • Infectious Disease • Novel Coronavirus Disease

Evaluation of 28-day estradiol and progesterone vaginal rings in a phase 1 clinical pharmacokinetic study. (PubMed, Menopause) - "The 80/4 IVR and 160/8 IVR gave similar steady-state concentrations of E2 as seen with drug products approved by the US Food and Drug Administration for treatment of VMS and genitourinary symptoms of menopause. The E2 concentrations of this study support the potential of DARE-HRT1, a promising new option for hormone therapy for treatment of VMS and vaginal symptoms associated with menopause."

Journal • P1 data • PK/PD data • Women's Health

Husbands' concerns and experiences with the progesterone vaginal ring in three sub-Saharan African countries: a mixed methods study. (PubMed, Sex Reprod Health Matters) - "The findings suggest that self-managed health technologies such as PVR could expand women's choices and control over their reproductive decisions. The findings further suggest that sustainable use of such products could require linkages with appropriate health systems structures to address challenges with use if and when they arise."

Journal

In Vitro-In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone. (PubMed, Pharmaceutics) - "This study focused on developing a Level A IVIVC for progesterone vaginal rings (PVRs), a dosage form designed for the continuous delivery in vivo. Obtained results justified the use of the in vitro release testing in lieu of clinical studies for the BE assessment of any new PVRs batches. Finally, the possible use of the developed population IVIVC model as a simulator of virtual BE trials was explored through a case study."

Journal

Choosing and Using the Progesterone Vaginal Ring: Women's Lived Experiences in Three African Cities. (PubMed, Patient Prefer Adherence) - "However, prior to its introduction into new country contexts, formative data on women's perceptions of, and reactions to, the product need to inform country preparation processes. Such information would be useful for tailoring counseling around this contraceptive, as well as for product marketing and robust uptake of the method."

Clinical • Journal

Post-use ring weight and residual drug content as potential objective measures of user adherence to a contraceptive progesterone vaginal ring. (PubMed, Contraception) - "Post-use ring weight is highly correlated with residual progesterone content, a benchmark objective cumulative measure of adherence, and thus potentially useful as a surrogate objective measure of cumulative adherence to a progesterone-releasing vaginal ring."

Journal • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] HLA GENOTYPING IN JAPANESE PATIENT WITH MULTIPLE MYELOMA; AN EXPLORATORY BIOMARKER STUDY FOR PREDICTING RESPONSE AND TOXICITY OF MELPHALAN, PREDNISOLONE, AND BORTEZOMIB: AN ANCILLARY STUDY OF JCOG1105 (EHA 2020) - "HLA-B4006 and -DR1201 were more prevalent in the group with severe skin disorders compared to that in other groups (OR=7.47, P=0.019 and OR=5.55, P=0.034, respectively), while -DP0402 was less prevalent (OR=0.00, P=0.033) in the group with severe skin disorders. HLA genotyping may serve as a potential candidate biomarker for predicting Btz-induced toxicity and treatment response in MM patients before initiation of Btz therapy. Our exploratory results need to be confirmed in further validation studies."

Biomarker • Clinical • Gene Therapies • Hematological Disorders • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • Pain • Pneumonia

Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Grünenthal GmbH

New P1 trial • Biosimilar • Dyslipidemia • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer

Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India. (PubMed, Contraception) - "Efficacy and safety outcomes were comparable among women in both groups. Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users. Infant breastfeeding and growth patterns/well-being were favorable in both groups. Implications PVR, a user-controlled device, offers an additional contraceptive choice for lactating women for one-year postpartum use and can help to address the unmet need for contraception among postpartum women while encouraging breastfeeding to enhance infant growth and well-being."

Clinical • Journal

SARA: Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures (clinicaltrials.gov) - P3; N=352; Completed; Sponsor: Ferring Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Trial completion

Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women (clinicaltrials.gov) - P1; N=106; Completed; Sponsor: Grünenthal GmbH; Active, not recruiting ➔ Completed

Clinical • Trial completion

SARA: Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures (clinicaltrials.gov) - P3; N=352; Active, not recruiting; Sponsor: Ferring Pharmaceuticals; Recruiting ➔ Active, not recruiting; N=240 ➔ 352; Trial completion date: Mar 2019 ➔ Aug 2019; Trial primary completion date: Mar 2019 ➔ Aug 2019

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women (clinicaltrials.gov) - P1; N=106; Active, not recruiting; Sponsor: Grünenthal GmbH; Recruiting ➔ Active, not recruiting; N=60 ➔ 106

Clinical • Enrollment change • Enrollment closed