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0 Diseases |  |
2 Trials |
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2 Trials |  |
50 News |  |
- | Zoely (nomegestrol/estradiol) / Merck (MSD), estradiol/etonogestrel intravaginal ring (MK-8342B) / Merck (MSD)
Phase classification: A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012) (clinicaltrials.gov) - May 28, 2024
P2, N=666, Completed, Sponsor: Organon and Co
Phase classification: P2b --> P2
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Enrollment open: Zoely vs. Zoloft in Premenstrual Dysphoric Disorder (EUDRACT) - May 24, 2024
P2, N=160, Recruiting, Sponsor: Monash University
Phase classification: P2b --> P2 Not yet recruiting --> Recruiting
- ||||||||| Zoely (nomegestrol/estradiol) / Merck (MSD)
Trial completion date, Trial termination, Trial primary completion date: Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive (clinicaltrials.gov) - Feb 15, 2024
P3, N=2007, Terminated, Sponsor: Organon and Co
This decision was made for business reasons unrelated to safety. None of the pre-specified efficacy endpoints were analyzed.
- || Zoely (nomegestrol/estradiol) / Merck (MSD)
Clinical data, Review, Journal, Real-world evidence, Real-world effectiveness, Real-world: A review of the pharmacology, clinical outcomes, and real-world effectiveness, safety, and non-contraceptive effects of NOMAC/E2. (Pubmed Central) - Feb 6, 2024
None of the pre-specified efficacy endpoints were analyzed. Nomegestrol acetate +
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Journal: Is the multinational, surveillance PRO-E2 study informative for all countries? The Italian data on VTE and contraceptive effectiveness. (Pubmed Central) - Dec 12, 2023
This subgroup analysis of the PRO-E2 study provides comprehensive epidemiological data on the use of combined oral contraceptives in a large Italian cohort, with a higher prevalence of women over 35?years and smokers. The study confirms the low thromboembolic risk and high contraceptive effectiveness of NOMAC-E2 pill.
- ||||| Zoely (nomegestrol/estradiol) / Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date: Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive (clinicaltrials.gov) - Dec 11, 2023
P3, N=1878, Active, not recruiting, Sponsor: Organon and Co
The study confirms the low thromboembolic risk and high contraceptive effectiveness of NOMAC-E2 pill. Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Oct 2024 | Trial primary completion date: Mar 2024 --> Oct 2024
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Enrollment change: Zoely vs. Zoloft in Premenstrual Dysphoric Disorder (EUDRACT) - Sep 29, 2023
P2, N=160, Not yet recruiting, Sponsor: Monash University
Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Oct 2024 | Trial primary completion date: Mar 2024 --> Oct 2024 N=240 --> 160
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
New P2 trial: Zoely vs. Zoloft in Premenstrual Dysphoric Disorder (EUDRACT) - Sep 14, 2023
P2, N=240, Not yet recruiting, Sponsor: Monash University
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Journal, Real-world evidence, Real-world: NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study. (Pubmed Central) - Mar 27, 2023
No differential effect on acne, mood, and weight was observed between cohorts. NOMAC-E2 shows a significantly better contraceptive effectiveness in young women and has no differential effect on acne, mood, and weight compared to COC.
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Journal, Real-world evidence, Real-world: NOMAC-E2 compares to LNG combined oral contraceptives in women over forty: real-world PRO-E2 study. (Pubmed Central) - Mar 24, 2023
No differential effect on mood and weight was observed between cohorts. NOMAC-E2 can be considered a valid alternative to COC in perimenopausal women.
- Zoely (nomegestrol/estradiol) / Merck (MSD)
SPOSY 05 Sponsored Symposium Theramex; A large multinational Real-world study confirms efficacy and tolerability of Zoely (NOMAC/E2) (Van Eyck) - Jun 3, 2022 - Abstract #ESCRH2022ESCRH_288;
NOMAC-E2 can be considered a valid alternative to COC in perimenopausal women. Sponsored by Theramex
- Zoely (nomegestrol/estradiol) / Merck (MSD)
NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives and has no adverse effect on mood, acne or weight change in women under 25: real-world PRO-E2 study (exhibit) - Jun 3, 2022 - Abstract #ESCRH2022ESCRH_132;
NOMAC-E2 shows a favourable profile in young women, with a significantly better contraceptive effectiveness than the gold-standard COCLNG and without an association with negative changes in mood, acne and weight over time. [1] First-ever users of an eligible COC or restarting with an eligible COC (same COC as before or a new COC) after a break of at least 2 months.
- Zoely (nomegestrol/estradiol) / Merck (MSD)
NOMAC-E2 compares to LNG combined oral contraceptives in women over forty: real-world PRO-E2 study (Rysselberghe) - Jun 3, 2022 - Abstract #ESCRH2022ESCRH_77;
Thus, NOMAC-E2 can be considered a valid alternative to the gold standard in this population. [1] First-ever users of an eligible COC or restarting with an eligible COC (same COC as before or a new COC) after a break of at least 2 months.
- Zoely (nomegestrol/estradiol) / Merck (MSD)
NOMAC/E2 in perimenopausal women – evidence from PRO-E2 (HAll 1) - Apr 29, 2022 - Abstract #ISGE2022ISGE_596;
- Zoely (nomegestrol/estradiol) / Merck (MSD)
NOMAC-E2 compares to LNG combined oral contraceptives in women over forty: real-world PRO-E2 study (Hall 5) - Apr 29, 2022 - Abstract #ISGE2022ISGE_228;
Thus NOMAC-E2 can be considered a valid alternative to the gold standard in this population. *First-ever users of an eligible COC or restarting with an eligible COC (same COC as before or a new COC) after a break of at least 2 months.
- Zoely (nomegestrol/estradiol) / Merck (MSD)
NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives and has no adverse effect on mood, acne or weight change in women under 25: real-world PRO-E2 study (Hall 5) - Apr 29, 2022 - Abstract #ISGE2022ISGE_226;
Conclusions NOMAC-E2 shows a favourable profile in young women, with a significantly better contraceptive effectiveness than the gold-standard COCLNG and without an association with negative changes in mood, acne and weight over time. *First-ever users of an eligible COC or restarting with an eligible COC (same COC as before or a new COC) after a break of at least 2 months.
- |||||||||| Zoely (nomegestrol/estradiol) / Merck (MSD)
New P3 trial: Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive (clinicaltrials.gov) - Mar 2, 2022
P3, N=1878, Recruiting, Sponsor: Organon and Co
- || Zoely (nomegestrol/estradiol) / Merck (MSD)
Clinical, Journal: Prospective controlled cohort study on the safety of a monophasic oral contraceptive containing nomegestrol acetate (2.5mg) and 17β-oestradiol (1.5mg) (PRO-E2 study): risk of venous and arterial thromboembolism. (Pubmed Central) - Nov 29, 2021
The risk of all VTE and ATE was not higher in NOMAC-E2 users compared with COCLNG users. NOMAC-E2 use was not associated with a higher risk of VTE or ATE compared with COCLNG.
- || Zoely (nomegestrol/estradiol) / Merck (MSD)
Clinical, Journal: Unintended pregnancy in users of nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study. (Pubmed Central) - Nov 29, 2021
The HR of NOMAC-E2 vs COC was 0.45 (95% CI, 0.34-0.60; adjusted for age, body mass index, gravidity, COC user status, education level). NOMAC-E2 demonstrated superior contraceptive effectiveness compared to COC, likely due to the comparatively short hormone-free interval and possibly reinforced by the long half-life of NOMAC.
- || Zoely (nomegestrol/estradiol) / Merck (MSD)
Clinical, Journal: The effectiveness of quick starting oral contraception containing nomegestrol acetate and 17-β estradiol on ovulation inhibition: A randomized controlled trial. (Pubmed Central) - Dec 16, 2020
Quick starting COC during day7-9 of menstrual cycle can inhibit ovulation for more than 90%. The quick starting NOMAC/E2 is non-inferior to GS/EE for preventing ovulation and suppressing follicular growth.
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Journal: Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study. (Pubmed Central) - Dec 5, 2020
No treatment effect was observed on ARR after 12 weeks (sex steroids = 0.90 (0.58-1.39), placebo = 0.97 (0.63-1.50) (p = 0.79)). POPARTMUS failed showing efficacy of a NOMAc-E2 combination in preventing post-partum relapses.
- || Zoely (nomegestrol/estradiol) / Merck (MSD)
Clinical, Journal: Nomegestrol acetate/17beta-estradiol does not negatively alter the vascular resistance of clitoral arteries: a prospective, exploratory study. (Pubmed Central) - Dec 3, 2020
In the NOMAC/E2 group, at follow-up, uterine artery PI and acceleration were significantly reduced (p = 0.04), whereas no significant differences were observed in the HCs group; however, the change in uterine artery parameters did not differ significantly between the two groups. NOMAC/E2, differently from other COCs, does not negatively alter the vascular resistance of clitoral arteries and appears as a good contraceptive choice to protect both cardiovascular and sexual health.
- || ibuprofen / Generic mfg.
Clinical, P2b data, Journal: A phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of vaginal rings containing nomegestrol acetate or etonogestrel and 17β-estradiol in the treatment of women with primary dysmenorrhea. (Pubmed Central) - Apr 4, 2020
P2
This placebo-controlled study provides evidence that vaginal contraceptive rings containing NOMAC-E2 or ENG-E2 improve moderate to severe dysmenorrhea, across all of doses studied. This adds to the evidence that hormonal contraceptives are effective treatments for dysmenorrhea.
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Clinical, Journal: Treatment continuation and satisfaction in women using combined oral contraception with nomegestrol acetate and oestradiol: a multicentre, prospective cohort study (BOLERO). (Pubmed Central) - May 9, 2019
This adds to the evidence that hormonal contraceptives are effective treatments for dysmenorrhea. The real-world experience of women receiving NOMAC/E2 indicated very good treatment continuation, high satisfaction and significantly improved menstrual cycle-related symptoms.
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
New P4 trial: Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT (clinicaltrials.gov) - May 21, 2018
P4, N=112, Terminated, Sponsor: Mahidol University
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Trial completion: Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception (clinicaltrials.gov) - Mar 23, 2018
P4, N=69, Completed, Sponsor: Mahidol University
The real-world experience of women receiving NOMAC/E2 indicated very good treatment continuation, high satisfaction and significantly improved menstrual cycle-related symptoms. Recruiting --> Completed
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
New P4 trial: Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception (clinicaltrials.gov) - Mar 12, 2017
P4, N=80, Recruiting, Sponsor: Mahidol University
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Trial termination: Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448) (clinicaltrials.gov) - Dec 5, 2014
P3, N=3173, Terminated, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Completed Completed --> Terminated; Business reasons
- | Zoely (nomegestrol/estradiol) / Merck (MSD)
Enrollment open, Trial initiation date, Trial primary completion date: A New Treatment Option for Heavy Menstrual Bleeding (clinicaltrials.gov) - Nov 19, 2014
P4, N=30, Recruiting, Sponsor: Sydney Centre for Reproductive Health Research
Completed --> Terminated; Business reasons Not yet recruiting --> Recruiting | Initiation date: Nov 2012 --> Apr 2013 | Trial primary completion date: Dec 2013 --> Apr 2015
- ||||||| Zoely (nomegestrol/estradiol) / Merck (MSD)
Trial completion: Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448) (clinicaltrials.gov) - Feb 19, 2014
P3, N=3173, Completed, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting | Initiation date: Nov 2012 --> Apr 2013 | Trial primary completion date: Dec 2013 --> Apr 2015 Active, not recruiting --> Completed
- |||| Zoely (nomegestrol/estradiol) / Merck (MSD), estradiol/etonogestrel intravaginal ring (MK-8342B) / Merck (MSD)
Trial completion: A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012) (clinicaltrials.gov) - Nov 6, 2013
P2b, N=666, Completed, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Zoely (nomegestrol/estradiol) / Merck (MSD), estradiol/etonogestrel intravaginal ring (MK-8342B) / Merck (MSD)
Trial completion: A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057) (clinicaltrials.gov) - Oct 17, 2013
P2, N=439, Completed, Sponsor: Merck
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Zoely (nomegestrol/estradiol) / Merck (MSD)
Trial withdrawal: Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017) (clinicaltrials.gov) - Aug 20, 2013
P3, N=0, Withdrawn, Sponsor: Merck
Active, not recruiting --> Completed Not yet recruiting --> Withdrawn
- Zoely (nomegestrol/estradiol) / Merck (MSD)
Enrollment change: Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017) (clinicaltrials.gov) - Aug 20, 2013
P3, N=0, Withdrawn, Sponsor: Merck
Not yet recruiting --> Withdrawn N=144 --> 0
- Zoely (nomegestrol/estradiol) / Merck (MSD)
Trial initiation date: Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017) (clinicaltrials.gov) - Feb 19, 2013
P3, N=0, Withdrawn, Sponsor: Merck
N=144 --> 0 Initiation date: Apr 2013 --> Jul 2013
- Zoely (nomegestrol/estradiol) / Merck (MSD)
New P3 trial: Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017) (clinicaltrials.gov) - Nov 6, 2012
P3, N=0, Withdrawn, Sponsor: Merck
- Zoely (nomegestrol/estradiol) / Merck (MSD)
New P4 trial: A New Treatment Option for Heavy Menstrual Bleeding (clinicaltrials.gov) - Oct 24, 2012
P4, N=30, Not yet recruiting, Sponsor: Sydney Centre for Reproductive Health Research
- |||||| Zoely (nomegestrol/estradiol) / Merck (MSD), estradiol/etonogestrel intravaginal ring (MK-8342B) / Merck (MSD)
New P2b trial: A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012) (clinicaltrials.gov) - Oct 16, 2012
P2b, N=666, Completed, Sponsor: Merck Sharp & Dohme Corp.
- | Zoely (nomegestrol/estradiol) / Merck (MSD), estradiol/etonogestrel intravaginal ring (MK-8342B) / Merck (MSD)
New P2 trial: A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057) (clinicaltrials.gov) - Aug 20, 2012
P2, N=439, Completed, Sponsor: Merck
- |||||||||| Zoely (nomegestrol/estradiol) / Merck (MSD)
New P3 trial: Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448) (clinicaltrials.gov) - Aug 1, 2012
P3, N=3173, Completed, Sponsor: Merck Sharp & Dohme Corp.
- drospirenone/ethinyl estradiol / Generic mfg.
New P1 trial: Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in Women With Polycystic Ovary Syndrome (clinicaltrials.gov) - May 20, 2012
P1, N=10, Recruiting, Sponsor: Catholic University of the Sacred Heart