Status:
COMPLETED
Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)
Lead Sponsor:
Organon and Co
Conditions:
Contraception
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combi...
Eligibility Criteria
Inclusion
- Sexually active women, at risk for pregnancy and not planning to use condoms;
- Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles);
- At least 18 but not older than 50 years of age at the time of screening;
- Body mass index \>=17 and \<=35;
- Good physical and mental health;
- Willing to give informed consent in writing.
Exclusion
- Contraindications for contraceptive steroids
- In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
- Renal insufficiency;
- Hepatic dysfunction;
- Adrenal insufficiency.
- An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia \[CIN\], squamous intraepithelial lesion \[SIL\], carcinoma in situ, invasive carcinoma) at screening;
- Clinically relevant abnormal laboratory result at screening as judged by the investigator;
- Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
- Before spontaneous menstruation has occurred following a delivery or abortion;
- Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
- Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
- Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
- Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
2281 Patients enrolled
Trial Details
Trial ID
NCT00413062
Start Date
June 1 2006
End Date
August 1 2008
Last Update
February 9 2022
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