ContraceptionPhase 3NCT01723579
Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)
A Phase 3 study testing Nomegestrol acetate (NOMAC) and Estradiol (E2) in people with Contraception, run by Organon and Co.
Trial summary
This study will investigate the efficacy and safety of the monophasic combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in healthy fertile Indian women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Nomegestrol acetate (NOMAC) and Estradiol (E2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sexually active and at risk for pregnancy
- Of Indian descent, born in India, never emigrated out of India, with Indian
- home address
- Body mass index (BMI) ≥17 and ≤35 kg/m^2
Who cannot join
- Presence or history of venous or arterial thrombotic/thromboembolic events
- or cerebrovascular accident
- Presence or history of prodromi of a thrombosis
- History of migraine with focal neurological symptoms
- Diabetes mellitus with vascular involvement
- Presence of a severe or multiple risk factor(s) for venous or arterial
Show all 18Show fewer
- thrombosis
- Severe hypertension
- Severe dyslipoproteinemia
- Presence or history of pancreatitis associated with severe
- hypertriglyceridemia
- Presence or history of severe hepatic disease
- Undiagnosed vaginal bleeding
- Known or suspected pregnancy
- Currently breastfeeding or breastfeeding within 2 months of starting
- trial medication
- Investigational drug use or participation in another clinical trial within
- 2 months of signing Informed Consent Form for current trial
About this study
Official title: An Open-label, Multi-center Trial to Evaluate the Contraceptive Efficacy, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) in Indian Women. Protocol MK-8175A-017-00
This study will investigate the efficacy and safety of the monophasic
combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in
healthy fertile Indian women.
- Conditions
- Contraception
- Being tested
- Nomegestrol acetate (NOMAC), 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
Oral tablet with daily release of 2.5 mg
Estradiol (E2)Drug
Daily release of 1.5 mg
| Study group | Role | What they receive |
|---|---|---|
| NOMAC-E2 2.5 mg/1.5 mg | Experimental | Participants will receive combined oral contraceptive NOMAC-E2 2.5 mg/1.5 mg tablet for 13 consecutive 28-day cycles. Each 28-day cycle with consist of 24 active tablets and 4 placebo tablets taken at approximately the same time each day. Receives: Drug: Nomegestrol acetate (NOMAC); Drug: Estradiol (E2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of In-treatment Pregnancies
Measured: Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366)
Secondary outcomes (1)
Number of Participants Experiencing an Adverse Event (AE) or Serious AE
Measured: "From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startJul 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723579
- Sponsor's protocol ID
- P07057
- Other IDs
- MK-8175A-017
- Status last verified
- Feb 2022
- First submitted
- 6 Nov 2012
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Trial to Evaluate the Contraceptive Efficacy, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) in Indian Women. Protocol MK-8175A-017-00
- ClinicalTrials.gov ID
- NCT01723579
- Acronym / sponsor ID
- P07057
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the efficacy and safety of the monophasic
combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in
healthy fertile Indian women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOMAC-E2 2.5 mg/1.5 mg | Experimental | Drug: Nomegestrol acetate (NOMAC), Drug: Estradiol (E2)Participants will receive combined oral contraceptive NOMAC-E2 2.5 mg/1.5 mg tablet for 13 consecutive 28-day cycles. Each 28-day cycle with consist of 24 active tablets and 4 placebo tablets taken at approximately the same time each day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sexually active and at risk for pregnancy
- Of Indian descent, born in India, never emigrated out of India, with Indian
- home address
- Body mass index (BMI) ≥17 and ≤35 kg/m^2
Key exclusion criteria (18 listed)
- Presence or history of venous or arterial thrombotic/thromboembolic events
- or cerebrovascular accident
- Presence or history of prodromi of a thrombosis
- History of migraine with focal neurological symptoms
- Diabetes mellitus with vascular involvement
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)Oral tablet with daily release of 2.5 mg | Drug | NOMAC-E2 2.5 mg/1.5 mg |
| Estradiol (E2)Daily release of 1.5 mg | Drug | NOMAC-E2 2.5 mg/1.5 mg |
Primary outcome
Number of In-treatment Pregnancies
Time frame: Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366)
1 secondary outcome
Number of Participants Experiencing an Adverse Event (AE) or Serious AE
Time frame: "From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nomegestrol acetate (NOMAC) and Estradiol (E2) 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 4 inclusion and 18 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: withdrawn, as of the sponsor's last update on 16 Feb 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of In-treatment Pregnancies (time frame: Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2022.