ContraceptionPhase 2NCT01709318
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
A Phase 2 study testing Nomegestrol acetate (NOMAC), Etonogestrel (ENG) and Ethinyl estradiol (EE) in people with Contraception, run by Organon and Co.
Trial summary
The primary objective of this trial was to identify at least one next generation ring (NGR) that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of participants ovulation was observed in less than 15% of the participants at any time during the 3 treatment cycles of the study) and… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Nomegestrol acetate (NOMAC), Etonogestrel (ENG) and Ethinyl estradiol (EE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2012to 22 Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥18 and ≤35
- Regular cycles from 24 to 35 days in length, with an intra-individual variation of ±3 days permitted within this range
- Good physical and mental health
Who cannot join
- Diabetes mellitus with vascular involvement
- Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
- Severe dyslipoproteinemia
- Severe hypertension
- Presence or history of pancreatitis associated with severe hypertriglyceridaemia
- Presence or history of severe hepatic disease
Show all 13Show fewer
- Undiagnosed vaginal bleeding
- Known or suspected pregnancy
- Participation in another investigational drug study within 30 days prior to screening visit
- History of malignancy ≤5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Documented abnormal cervical smear result in 6 months prior to screening visit
- Sterilization using a fallopian tube occlusion device (e.g., Essure method)
- Sex hormone therapy within 2 months prior to screening visit for purpose other than contraception, or injectable hormonal contraception within 6 months prior to screening
About this study
Official title: A Multicenter, Randomized, Partially-blinded, Phase IIb Dose-finding Study on Ovarian Function, Vaginal Bleeding Pattern, and Pharmacokinetics Associated With the Use of Combined Vaginal Rings Releasing 17β-estradiol Plus Three Different Doses of Either Nomegestrol Acetate or Etonogestrel in Healthy Women Aged 18-35 Years. Protocol MK-8175A/MK-8342B 012
The primary objective of this trial was to identify at least one next generation ring (NGR) that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of participants ovulation was observed in less than 15% of the participants at any time during the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the incidence of BTB-S.
- Conditions
- Contraception
- Being tested
- Nomegestrol acetate (NOMAC), Etonogestrel (ENG), Ethinyl estradiol (EE), Estradiol (E2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nomegestrol acetate (NOMAC)Drug
Daily release of 500, 700, or 900 μg.
Etonogestrel (ENG)Drug
Daily release of 75, 100, 120 or 125 μg
Ethinyl estradiol (EE)Drug
Daily release of 15 μg
Estradiol (E2)Drug
Daily release of 300 μg
| Study group | Role | What they receive |
|---|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day | Experimental | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Nomegestrol acetate (NOMAC); Drug: Estradiol (E2) |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day | Experimental | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Nomegestrol acetate (NOMAC); Drug: Estradiol (E2) |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day | Experimental | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Nomegestrol acetate (NOMAC); Drug: Estradiol (E2) |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day | Experimental | Participants will receive etonogestrel 17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Etonogestrel (ENG); Drug: Estradiol (E2) |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day | Experimental | Participants will receive etonogestrel 17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Etonogestrel (ENG); Drug: Estradiol (E2) |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day | Experimental | Participants will receive etonogestrel 17β-estradiol (ENG-E2)125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Etonogestrel (ENG); Drug: Estradiol (E2) |
| NuvaRing® | Active comparator | Participants will receive NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Etonogestrel (ENG); Drug: Ethinyl estradiol (EE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Ovulation Incidence, by Cycle
Ovulation was defined as having 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure >15 mm in size).
Measured: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle
Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.
Measured: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3
Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.
Measured: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)
Secondary outcomes (8)
Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2
Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.
Measured: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
Intensity of Withdrawal Bleeding During Cycle 2
Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.
Measured: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3
Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.
Measured: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)
Percentage of Participants Who Experienced At Least One Adverse Event
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Measured: Up to ~92 days
Percentage of Participants Who Experienced At Least One Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment.
Measured: Up to ~92 days
Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Measured: Up to ~92 days
Percentage of Participants With Any Drug-Related Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Measured: Up to ~92 days
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Measured: Up to ~92 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study start12 Dec 2012
- Primary completion22 Oct 2013
- Study completion22 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709318
- Sponsor's protocol ID
- P06109
- Other IDs
- 2012-002459-41, P06109, MK-8175A/MK-8342B-012
- Status last verified
- Feb 2022
- First submitted
- 16 Oct 2012
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Duijkers I, Klipping C, Heger-Mahn D, Fayad GN, Frenkl TL, Cruz SM, Korver T. Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17beta-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing. Eur J Contracept Reprod Health Care. 2018 Aug;23(4):245-254. doi: 10.1080/13625187.2018.1506101. Epub 2018 Sep 11.
PubMed 30203681
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Partially-blinded, Phase IIb Dose-finding Study on Ovarian Function, Vaginal Bleeding Pattern, and Pharmacokinetics Associated With the Use of Combined Vaginal Rings Releasing 17β-estradiol Plus Three Different Doses of Either Nomegestrol Acetate or Etonogestrel in Healthy Women Aged 18-35 Years. Protocol MK-8175A/MK-8342B 012
- ClinicalTrials.gov ID
- NCT01709318
- Acronym / sponsor ID
- P06109
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2012 (actual)
- Primary completion
- 22 Oct 2013 (actual)
- Study completion
- 22 Oct 2013 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 5 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial was to identify at least one next generation ring (NGR) that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of participants ovulation was observed in less than 15% of the participants at any time during the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the incidence of BTB-S.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day | Experimental | Drug: Nomegestrol acetate (NOMAC), Drug: Estradiol (E2)Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day | Experimental | Drug: Nomegestrol acetate (NOMAC), Drug: Estradiol (E2)Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day | Experimental | Drug: Nomegestrol acetate (NOMAC), Drug: Estradiol (E2)Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day | Experimental | Drug: Etonogestrel (ENG), Drug: Estradiol (E2)Participants will receive etonogestrel 17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day | Experimental | Drug: Etonogestrel (ENG), Drug: Estradiol (E2)Participants will receive etonogestrel 17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day | Experimental | Drug: Etonogestrel (ENG), Drug: Estradiol (E2)Participants will receive etonogestrel 17β-estradiol (ENG-E2)125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| NuvaRing® | Active comparator | Drug: Etonogestrel (ENG), Drug: Ethinyl estradiol (EE)Participants will receive NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥18 and ≤35
- Regular cycles from 24 to 35 days in length, with an intra-individual variation of ±3 days permitted within this range
- Good physical and mental health
Key exclusion criteria (13 listed)
- Diabetes mellitus with vascular involvement
- Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
- Severe dyslipoproteinemia
- Severe hypertension
- Presence or history of pancreatitis associated with severe hypertriglyceridaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nomegestrol acetate (NOMAC)Daily release of 500, 700, or 900 μg. | Drug | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day, Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day, Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day |
| Etonogestrel (ENG)Daily release of 75, 100, 120 or 125 μg | Drug | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day, Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day, Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day, NuvaRing® |
| Ethinyl estradiol (EE)Daily release of 15 μg | Drug | NuvaRing® |
| Estradiol (E2)Daily release of 300 μg | Drug | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day, Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day, Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day, Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day, Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day, Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day |
Primary outcome
Percentage of Participants With Ovulation Incidence, by Cycle
Time frame: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
Ovulation was defined as having 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure >15 mm in size).
Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle
Time frame: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.
Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3
Time frame: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)
Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.
8 secondary outcomes
Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2
Time frame: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
Intensity of Withdrawal Bleeding During Cycle 2
Time frame: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3
Time frame: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)
Percentage of Participants Who Experienced At Least One Adverse Event
Time frame: Up to ~92 days
Percentage of Participants Who Experienced At Least One Serious Adverse Event
Time frame: Up to ~92 days
Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event
Time frame: Up to ~92 days
Percentage of Participants With Any Drug-Related Serious Adverse Event
Time frame: Up to ~92 days
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to ~92 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30203681Duijkers I, Klipping C, Heger-Mahn D, Fayad GN, Frenkl TL, Cruz SM, Korver T. Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17beta-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing. Eur J Contracept Reprod Health Care. 2018 Aug;23(4):245-254. doi: 10.1080/13625187.2018.1506101. Epub 2018 Sep 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nomegestrol acetate (NOMAC), Etonogestrel (ENG) and Ethinyl estradiol (EE) in people with Contraception, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Ovulation Incidence, by Cycle (time frame: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.