DysmenorrheaPhase 2NCT01670656

A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)

A Phase 2 study testing Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR), Etonogestrel containing contraceptive vaginal ring (ENG-CVR) and Ibuprofen in people with Dysmenorrhea, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Dysmenorrhea
What is being tested?: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR), Etonogestrel containing contraceptive vaginal ring (ENG-CVR) and Ibuprofen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 439 participants
Where: No sites listed yet
Study dates: 21 Jan 2013to 12 Sep 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 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Body mass index (BMI) ≥18 and ≤35
Established diagnosis of primary dysmenorrhea
If of child-bearing potential must agree to use condoms for contraception during the entire screening period, treatment period, and post-treatment period until the final study visit, unless she or her partner are surgically sterilized
Agree to stop using hormonal contraceptive (combined or progestin-only), or a non hormonal intrauterine device (IUD)
Regular menstrual cycles ranging from 24 to 35 days in length

Who cannot join

Any of the following contraindications to the use of contraceptive steroids including: presence or a history of venous or arterial thrombotic/thromboembolic events or cerebrovascular accident (stroke, history of migraine with focal neurological symptoms, diabetes mellitus with vascular involvement, severe or multiple risk factor(s) for venous or arterial thrombosis, severe dyslipoproteinemia, severe hypertension, pancreatitis or a history thereof if associated with severe hypertriglyceridaemia, presence or history of severe hepatic (liver) disease, including benign or malignant tumors, known or suspected sex steroid-influenced malignancies, and/or undiagnosed vaginal bleeding
Pregnant or breastfeeding
Secondary dysmenorrhea
Has not had spontaneous menstruation following a delivery or abortion
Participated in an investigational drug study within 30 days
History of malignancy ≤5 years

Show all 12Show fewer

Documented abnormal cervical smear result within 6 months
Use of recreational or illicit drugs
Consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
Allergy/sensitivity to ibuprofen, or any contraindication to its use, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, or other nonsteroidal anti inflammatory drugs
Has been sterilized using a fallopian tube occlusion device
Is receiving, or has received sex hormones for any purpose other than contraception within 2 months or injectable hormonal contraception within 6 months

About this study

Official title: A Multicenter, Randomized, Partially Blinded, Placebo-controlled Clinical Trial to Evaluate the Effect on Primary Dysmenorrhea of Vaginal Rings With an Average Daily Release of 700 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 900 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 100 μg Etonogestrel (ENG) and 300 μg E2, or 125 μg Etonogestrel (ENG) and 300 μg E2. Protocol MK-8175A/MK-8342B 057 (Abbreviated as P057), Also Known as SCH900121/SCH900432 08257 (Abbreviated as P08257)

Read the detailed description

The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea. The intake of ibuprofen rescue medication and the impact on daily life is investigated: change from baseline data of these two variables will be compared between each of the four active ring groups, separately, and the placebo ring group. Furthermore, the study assesses the measurement characteristics and psychometric properties of a newly developed Dysmenorrhea Daily Dairy. Vaginal bleeding pattern and general safety and tolerability will also be evaluated.

Conditions: Dysmenorrhea
Being tested: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR), Etonogestrel containing contraceptive vaginal ring (ENG-CVR), Placebo, Ibuprofen
Medical subject headings: Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)Drug
Also called SCH900121, MK-8175A
Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles
Etonogestrel containing contraceptive vaginal ring (ENG-CVR)Drug
Also called SCH900432, MK-8342B
Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles
PlaceboDrug
Placebo to match vaginal ring, intravaginally for two 28-day cycles
IbuprofenDrug
Also called Motrin
Ibuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets)

Study groups in NCT01670656
Study group	Role	What they receive
NOMAC-E2 700/300 mcg	Experimental	NOMAC-E2 700/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR); Drug: Ibuprofen
NOMAC-E2 900/300 mcg	Experimental	NOMAC-E2 900/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR); Drug: Ibuprofen
ENG-E2 100/300 mcg	Experimental	ENG-E2 100/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR); Drug: Ibuprofen
ENG-E2 125/300 mcg	Experimental	ENG-E2 125/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR); Drug: Ibuprofen
Placebo	Placebo comparator	Placebo will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. Receives: Drug: Placebo; Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2
The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: "Cramps") in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe).
Measured: Baseline and Day 29 to 56 (Cycle 2)

Secondary outcomes (3)

Change From Baseline in Total Mean Impact Score Through Cycle 2
Total Mean Impact Score is the mean of the sum of the daily responses to questions 6, 8, 9, and 10 in the Dysmenorrhea Daily e-Dairy, as recorded within the menstrual cramping pain analysis window. These questions assessed how much interference there was from pelvic cramping pain on work/school activities (Q6), physical activities (Q8), social/leisure activities (Q9) and sleep (Q10). Each question was rated on a 5-point (0-4) scale, with 0 being "not at all", 1 "slightly", 2 "moderately", 3 "quite a bit" and 4 "extremely". The total mean impact score could thus range from 0 (lowest possible impact) to 16 (highest possible impact).
Measured: Baseline and Day 29 to 56 (Cycle 2)
Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2
Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.
Measured: Baseline and Day 29 to 56 (Cycle 2)
Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2
Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.
Measured: Baseline and Day 29 to 56 (Cycle 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 201312 Sep 2013

First posted22 Aug 2012 (estimated)
Study start21 Jan 2013
Primary completion11 Sep 2013
Study completion12 Sep 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 DysmenorrheaStudies 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: 439 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01670656
Sponsor's protocol ID: P08257
Other IDs: 2012-002449-40, MK-8175A/MK-8342B-057
Status last verified: Feb 2022
First submitted: 14 Aug 2012
Last updated: 28 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fox MC, Klipping C, Nguyen AM, Frenkl TL, Cruz SM, Wang Y, Korver T. 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 17beta-estradiol in the treatment of women with primary dysmenorrhea. Contraception. 2019 Feb;99(2):125-130. doi: 10.1016/j.contraception.2018.10.009. Epub 2018 Nov 12.
PubMed 30439359

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Dysmenorrhea trials

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, Placebo-controlled Clinical Trial to Evaluate the Effect on Primary Dysmenorrhea of Vaginal Rings With an Average Daily Release of 700 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 900 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 100 μg Etonogestrel (ENG) and 300 μg E2, or 125 μg Etonogestrel (ENG) and 300 μg E2. Protocol MK-8175A/MK-8342B 057 (Abbreviated as P057), Also Known as SCH900121/SCH900432 08257 (Abbreviated as P08257)
ClinicalTrials.gov ID: NCT01670656
Acronym / sponsor ID: P08257
Conditions: Dysmenorrhea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 439 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 21 Jan 2013 (actual)
Primary completion: 11 Sep 2013 (actual)
Study completion: 12 Sep 2013 (actual)
First posted: 22 Aug 2012 (estimated)
Results: Posted 24 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
NOMAC-E2 700/300 mcg	Experimental	Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR), Drug: IbuprofenNOMAC-E2 700/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
NOMAC-E2 900/300 mcg	Experimental	Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR), Drug: IbuprofenNOMAC-E2 900/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
ENG-E2 100/300 mcg	Experimental	Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR), Drug: IbuprofenENG-E2 100/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
ENG-E2 125/300 mcg	Experimental	Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR), Drug: IbuprofenENG-E2 125/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
Placebo	Placebo comparator	Drug: Placebo, Drug: IbuprofenPlacebo will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Body mass index (BMI) ≥18 and ≤35
Established diagnosis of primary dysmenorrhea
If of child-bearing potential must agree to use condoms for contraception during the entire screening period, treatment period, and post-treatment period until the final study visit, unless she or her partner are surgically sterilized
Agree to stop using hormonal contraceptive (combined or progestin-only), or a non hormonal intrauterine device (IUD)
Regular menstrual cycles ranging from 24 to 35 days in length

Key exclusion criteria (12 listed)

Any of the following contraindications to the use of contraceptive steroids including: presence or a history of venous or arterial thrombotic/thromboembolic events or cerebrovascular accident (stroke, history of migraine with focal neurological symptoms, diabetes mellitus with vascular involvement, severe or multiple risk factor(s) for venous or arterial thrombosis, severe dyslipoproteinemia, severe hypertension, pancreatitis or a history thereof if associated with severe hypertriglyceridaemia, presence or history of severe hepatic (liver) disease, including benign or malignant tumors, known or suspected sex steroid-influenced malignancies, and/or undiagnosed vaginal bleeding
Pregnant or breastfeeding
Secondary dysmenorrhea
Has not had spontaneous menstruation following a delivery or abortion
Participated in an investigational drug study within 30 days

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 contraceptive vaginal ring (NOMAC-CVR)Also: SCH900121, MK-8175AEither 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles	Drug	NOMAC-E2 700/300 mcg, NOMAC-E2 900/300 mcg
Etonogestrel containing contraceptive vaginal ring (ENG-CVR)Also: SCH900432, MK-8342BEither 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles	Drug	ENG-E2 100/300 mcg, ENG-E2 125/300 mcg
PlaceboPlacebo to match vaginal ring, intravaginally for two 28-day cycles	Drug	Placebo
IbuprofenAlso: MotrinIbuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets)	Drug	ENG-E2 100/300 mcg, ENG-E2 125/300 mcg, NOMAC-E2 700/300 mcg, NOMAC-E2 900/300 mcg, Placebo

Primary outcome

Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2
Time frame: Baseline and Day 29 to 56 (Cycle 2)
The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: "Cramps") in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe).

3 secondary outcomes

Change From Baseline in Total Mean Impact Score Through Cycle 2
Time frame: Baseline and Day 29 to 56 (Cycle 2)
Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2
Time frame: Baseline and Day 29 to 56 (Cycle 2)
Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2
Time frame: Baseline and Day 29 to 56 (Cycle 2)

Results and safety

Results posted to the registry on 24 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NOMAC-E2 700/300 mcg	86	83
NOMAC-E2 900/300 mcg	91	84
ENG-E2 100/300 mcg	87	79
ENG-E2 125/300 mcg	85	79
Placebo	90	79

Primary outcome: Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2

Time frame: Baseline and Day 29 to 56 (Cycle 2). Least squares mean (95% Confidence Interval). Unit: Units on a scale

Measure	NOMAC-E2 700/300 mcg n = 85	NOMAC-E2 900/300 mcg n = 91	ENG-E2 100/300 mcg n = 86	ENG-E2 125/300 mcg n = 85	Placebo n = 90
Value	-1.7 (-2.0 to -1.5)	-1.7 (-1.9 to -1.5)	-1.9 (-2.1 to -1.7)	-1.7 (-1.9 to -1.5)	-1.2 (-1.4 to -0.9)

NOMAC-E2 700/300 mcg vs Placebo: Difference in Least Squares Means: -0.6 (95% CI -1.0 to -0.2), p < 0.001, cLDA
NOMAC-E2 900/300 mcg vs Placebo: Difference in Least Squares Means: -0.6 (95% CI -0.9 to -0.2), p < 0.001, cLDA
ENG-E2 100/300 mcg vs Placebo: Difference in Least Squares Means: -0.8 (95% CI -1.1 to -0.4), p < 0.001, cLDA

Population analysed: All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Menstrual Cramping Pain Score

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 64 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NOMAC-E2 (700/300 mcg)	0 of 86 (0%)	12 of 86 (14%)	Not reported
NOMAC-E2 (900/300 mcg)	1 of 91 (1.1%)	11 of 91 (12.1%)	Not reported
ENG-E2 (100/300 mcg)	0 of 86 (0%)	14 of 86 (16.3%)	Not reported
ENG-E2 (125/300 mcg)	1 of 85 (1.2%)	7 of 85 (8.2%)	Not reported
Placebo	0 of 90 (0%)	11 of 90 (12.2%)	Not reported

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.
Derived from this study: PubMed 30439359Fox MC, Klipping C, Nguyen AM, Frenkl TL, Cruz SM, Wang Y, Korver T. 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 17beta-estradiol in the treatment of women with primary dysmenorrhea. Contraception. 2019 Feb;99(2):125-130. doi: 10.1016/j.contraception.2018.10.009. Epub 2018 Nov 12.
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?

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 5 inclusion and 12 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. Some participants in this study may receive a placebo. 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 24 Aug 2017). 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?

Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2 (time frame: Baseline and Day 29 to 56 (Cycle 2)). 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 NCT01670656, 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.