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- || Milprosa (progesterone vaginal ring) / Ferring
P1 data, PK/PD data, Journal: Evaluation of 28-day estradiol and progesterone vaginal rings in a phase 1 clinical pharmacokinetic study. (Pubmed Central) - Mar 28, 2023
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.
- | Milprosa (progesterone vaginal ring) / Ferring
Journal: Husbands' concerns and experiences with the progesterone vaginal ring in three sub-Saharan African countries: a mixed methods study. (Pubmed Central) - Aug 22, 2022
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.
- || Milprosa (progesterone vaginal ring) / Ferring
Clinical, Journal: Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India. (Pubmed Central) - Oct 20, 2021
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.
- | progesterone / Generic mfg.
Journal: In Vitro-In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone. (Pubmed Central) - Mar 7, 2021
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.
- || Milprosa (progesterone vaginal ring) / Ferring
Clinical, Journal: Choosing and Using the Progesterone Vaginal Ring: Women's Lived Experiences in Three African Cities. (Pubmed Central) - Oct 20, 2020
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.
- | Milprosa (progesterone vaginal ring) / Ferring
Journal: Post-use ring weight and residual drug content as potential objective measures of user adherence to a contraceptive progesterone vaginal ring. (Pubmed Central) - Sep 19, 2020
Such information would be useful for tailoring counseling around this contraceptive, as well as for product marketing and robust uptake of the method. 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.
- bortezomib / Generic mfg., prednisolone / Generic mfg., melphalan / Generic mfg.
[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 () - May 16, 2020 - Abstract #EHA2020EHA_2383;
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.
- | Milprosa (progesterone vaginal ring) / Ferring
Trial completion: SARA: Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures (clinicaltrials.gov) - Aug 28, 2019
P3, N=352, Completed, Sponsor: Ferring Pharmaceuticals
Our exploratory results need to be confirmed in further validation studies. Active, not recruiting --> Completed
- | Trial completion: Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women (clinicaltrials.gov) - Jun 5, 2019
P1, N=106, Completed, Sponsor: Gr
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Milprosa (progesterone vaginal ring) / Ferring
Journal: Introducing the Progesterone Vaginal Ring (PVR) as a New Option for Postpartum Family Planning in Sub-Saharan Africa: Insights from Engagements with Stakeholders. (Pubmed Central) - May 7, 2019
The high acceptability rate in each country and the support expressed by government and other stakeholders have provided impetus for registration of the product in each country. Learning from this process could also direct how other family planning and reproductive health commodities would be introduced in the future.
- ||||| Milprosa (progesterone vaginal ring) / Ferring
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: SARA: Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures (clinicaltrials.gov) - Apr 4, 2019
P3, N=352, Active, not recruiting, Sponsor: Ferring Pharmaceuticals
Learning from this process could also direct how other family planning and reproductive health commodities would be introduced in the future. Recruiting --> Active, not recruiting | N=240 --> 352 | Trial completion date: Mar 2019 --> Aug 2019 | Trial primary completion date: Mar 2019 --> Aug 2019
- | Enrollment closed, Enrollment change: Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women (clinicaltrials.gov) - Feb 5, 2019
P1, N=106, Active, not recruiting, Sponsor: Gr
Recruiting --> Active, not recruiting | N=240 --> 352 | Trial completion date: Mar 2019 --> Aug 2019 | Trial primary completion date: Mar 2019 --> Aug 2019 Recruiting --> Active, not recruiting | N=60 --> 106
- | Enrollment change: Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women (clinicaltrials.gov) - Dec 8, 2018
P1, N=60, Recruiting, Sponsor: Gr
Recruiting --> Active, not recruiting | N=60 --> 106 N=40 --> 60
- || New P1 trial: Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women (clinicaltrials.gov) - Nov 9, 2018
P1, N=40, Recruiting, Sponsor: Gr
- | Milprosa (progesterone vaginal ring) / Ferring
Enrollment open: SARA: Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures (clinicaltrials.gov) - Jul 30, 2018
P3, N=240, Recruiting, Sponsor: Ferring Pharmaceuticals
N=40 --> 60 Not yet recruiting --> Recruiting
- |||||||||| Milprosa (progesterone vaginal ring) / Ferring
New P3 trial: SARA: Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures (clinicaltrials.gov) - Jul 15, 2018
P3, N=240, Not yet recruiting, Sponsor: Ferring Pharmaceuticals
- ||| Milprosa (progesterone vaginal ring) / Ferring
Trial completion: A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women (clinicaltrials.gov) - Sep 5, 2014
P1, N=56, Completed, Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || Milprosa (progesterone vaginal ring) / Ferring
Enrollment closed: A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women (clinicaltrials.gov) - Jul 30, 2014
P1, N=56, Active, not recruiting, Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Milprosa (progesterone vaginal ring) / Ferring
Trial completion: Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement (clinicaltrials.gov) - May 10, 2014
P2, N=20, Completed, Sponsor: Duramed Research
Recruiting --> Active, not recruiting No longer recruiting --> Completed
- ||| Milprosa (progesterone vaginal ring) / Ferring
New P1 trial: A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women (clinicaltrials.gov) - Mar 18, 2014
P1, N=56, Recruiting, Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.