Suppression of OvulationPhase 2NCT01361958
Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol
A Phase 2 study testing NOMAC in people with Suppression of Ovulation, run by Theramex.
Trial summary
The aim of the present study was to evaluate the ability of several doses of NOMAC in combination with E2 to inhibit ovulation and to assess changes in the gonadotropin and ovarian hormone profiles, in comparison to a control cycle in healthy-volunteer premenopausal women. 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
- Suppression of Ovulation
- What is being tested?
- NOMAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Feb 1997to Sep 1998
- Phase
- Phase 2
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female premenopausal healthy volunteers having given their informed written consent at the first selection visit,
- Registered with Social Security in agreement with the French Law on biomedical research on volunteers,
- Sufficiently co-operative to meet the needs of the study,
- Accepting not to become pregnant during the trial,
- Accepting the use of condoms as the single authorized contraceptive means during the trial,
- With a diurnal and regular job or activity,
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- Aged 18 to 35 years old inclusive,
- Non-smokers or current smokers of less than 10 cigarettes/day,
- With normal eating habits,
- With a body mass index between 17 and 27 inclusive,
Who cannot join
- Participation in another clinical trial,
- Blood donation in the three months prior to Visit V1 or intention to donate blood during the trial or within the three months following the trial completion,
- Virgins, because of the gynecological examination,
- Subjects who were within the exclusion period in the Healthy Volunteers National Register of the French Ministry of Health,
- Forfeiture of freedom by administrative or legal award or under guardianship,
- No possible contact in case of emergency,
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- Strenuous physical activity planned during the trial. Concerning the gynecological status and examination
- History of major medical, psychiatric illness or surgery,
- Any acute or chronic systemic disease or disorder,
- History of hypersensitivity to at least one drug (abnormal drug reaction or idiosyncrasy or asthma),
- Abuse of alcohol i.e. history or evidence of acute or chronic abuse, more than 45 g of alcohol per day,
- Excessive drinking of tea, coffee, chocolate, and/or beverages containing caffeine (>5 cups/day or approximately 500 mg of caffeine per day),
- Current vascular pathology or with a past history of thrombo-embolic disease, arterial hypertension (BPS ≥ 160 mm Hg or BPD ≥ 95 mm Hg), coronary artery disease, valvulopathy; thrombogenic cardiac rhythm disturbances, cerebrovascular disease, ocular pathology of vascular origin,
- Cancer or progressive hematological disorder,
- Current or past history of pituitary tumors,
- Epilepsy,
- Known hyperprolactinemia,
- Known renal insufficiency,
- Severe or recent liver disease or symptomatic vesicular lithiasis, or recurrent cholestasis or recurring pruritus of pregnancy,
- Abnormality (> 1N) in liver function on the selection laboratory investigation (ALT or AST > 50 IU/L or alkaline phosphatases > 125 IU/L or total bilirubin > 22 μmol/L or GGT > 70 IU/L),
- Known diabetes or fasting blood sugar > 6.2 mmol/L (1N) at the selection laboratory investigation,
- Uncontrolled treated dyslipidemia or cholesterolemia > 5.2 mmol/L (93%N), then > 6.2 mmol/L (110%N) after protocol amendment during the course of the study, or triglyceridemia > 1.80 mmol/L (79 %N) at the selection laboratory investigation,
- Plasma creatinine > 115 μmol/L (1N),
- Abnormality in any of the hematology parameters,
- Positive results at any of the serologies (HBs antigen, HCV antibodies, HIV 1 \& 2 antibodies) performed at V1,
- Positive result for β-HCG at any measurements (i.e. β-HCG > 5 mIU/mL),
- Abnormality in the baseline EKG,
- Connective tissue disorder,
- Porphyria,
- Otosclerosis,
- Abnormality at the medical examination performed at V1 which included a neurological examination,
- Past history or clinical evidence of any malignant tumor or benign disease of the breasts or uterus or ovary (including endometriosis, leiomyomas, polycystic ovaries ...),
- Vaginal infection at the vaginal bacteriological examination performed at V1. After protocol amendment during the course of the study, infection diagnosed at the vaginal bacteriology or at the cervico-vaginal smear was removed from the exclusion criteria list.
- Hysterectomy, even partial, or endometrectomy,
- Pregnancy,
- Childbirth, breast-feeding, miscarriage or termination of pregnancy in the year prior to V1,
About this study
Official title: Double-blind, Comparative, Randomized, Single Center, Between-subject, Dose-finding Clinical Trial to Compare 4 Doses of the Combination 17beta-estradiol/Nomegestrol Acetate Administered From Day 1 to Day 21 of the Menstrual Cycle on the Inhibition of Ovulation
The aim of the present study was to evaluate the ability of several doses of NOMAC in combination with E2 to inhibit ovulation and to assess changes in the gonadotropin and ovarian hormone profiles, in comparison to a control cycle in healthy-volunteer premenopausal women.
The study was also designed to check whether the combined administration of E2 and NOMAC at the dose of 2.5 mg daily induces any changes in the effects of the progestin compared to when it is given alone.
- Conditions
- Suppression of Ovulation
- Being tested
- NOMAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOMACDrug
| Study group | Role | What they receive |
|---|---|---|
| T1 received 0.625 mg NOMAC + 1.5 mg E2 | Experimental | Not described Receives: Drug: NOMAC |
| T2 received 1.25 mg NOMAC + 1.5 mg E2 | Experimental | Not described Receives: Drug: NOMAC |
| T3 received 2.5 mg NOMAC + 1.5 mg E2 | Experimental | Not described Receives: Drug: NOMAC |
| T4 received 2.5 mg NOMAC + Lactose | Experimental | Not described Receives: Drug: NOMAC |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startFeb 1997
- Primary completionNov 1997
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suppression of OvulationStudies 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
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theramex
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361958
- Sponsor's protocol ID
- 96-ESC/NOM-1-RD
- Status last verified
- May 2011
- First submitted
- 25 May 2011
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Comparative, Randomized, Single Center, Between-subject, Dose-finding Clinical Trial to Compare 4 Doses of the Combination 17beta-estradiol/Nomegestrol Acetate Administered From Day 1 to Day 21 of the Menstrual Cycle on the Inhibition of Ovulation
- ClinicalTrials.gov ID
- NCT01361958
- Acronym / sponsor ID
- 96-ESC/NOM-1-RD
- Conditions
- Suppression of Ovulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- TheramexIndustry (pharma, biotech, devices)
- Study start
- Feb 1997
- Primary completion
- Nov 1997 (actual)
- Study completion
- Sep 1998 (actual)
- First posted
- 27 May 2011 (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.
The aim of the present study was to evaluate the ability of several doses of NOMAC in combination with E2 to inhibit ovulation and to assess changes in the gonadotropin and ovarian hormone profiles, in comparison to a control cycle in healthy-volunteer premenopausal women.
The study was also designed to check whether the combined administration of E2 and NOMAC at the dose of 2.5 mg daily induces any changes in the effects of the progestin compared to when it is given alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T1 received 0.625 mg NOMAC + 1.5 mg E2 | Experimental | Drug: NOMAC |
| T2 received 1.25 mg NOMAC + 1.5 mg E2 | Experimental | Drug: NOMAC |
| T3 received 2.5 mg NOMAC + 1.5 mg E2 | Experimental | Drug: NOMAC |
| T4 received 2.5 mg NOMAC + Lactose | Experimental | Drug: NOMAC |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female premenopausal healthy volunteers having given their informed written consent at the first selection visit,
- Registered with Social Security in agreement with the French Law on biomedical research on volunteers,
- Sufficiently co-operative to meet the needs of the study,
- Accepting not to become pregnant during the trial,
- Accepting the use of condoms as the single authorized contraceptive means during the trial,
Key exclusion criteria (36 listed)
- Participation in another clinical trial,
- Blood donation in the three months prior to Visit V1 or intention to donate blood during the trial or within the three months following the trial completion,
- Virgins, because of the gynecological examination,
- Subjects who were within the exclusion period in the Healthy Volunteers National Register of the French Ministry of Health,
- Forfeiture of freedom by administrative or legal award or under guardianship,
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 |
|---|---|---|
| NOMAC | Drug | T1 received 0.625 mg NOMAC + 1.5 mg E2, T2 received 1.25 mg NOMAC + 1.5 mg E2, T3 received 2.5 mg NOMAC + 1.5 mg E2, T4 received 2.5 mg NOMAC + Lactose |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
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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 2 study testing NOMAC in people with Suppression of Ovulation, run by Theramex.
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 10 inclusion and 36 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 27 May 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 27 May 2011.