Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol

NCT01361958 | Completed Phase 2

• 1 other identifier: 96-ESC/NOM-1-RD
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Study Arms (4)

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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,

You may not qualify if:

• 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,
• Forfeiture of freedom by administrative or legal award or under guardianship,
• No possible contact in case of emergency,
• 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,

Sponsors & Collaborators

• Theramex: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: May 27, 2011
• Study Start: February 1, 1997
• Primary Completion: November 1, 1997
• Study Completion: September 1, 1998
• Last Updated: May 27, 2011

Record last verified: 2011-05