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Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
This study has been completed.
First Received: August 2, 2007   Last Updated: October 2, 2009   History of Changes
Sponsor: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00511199
  Purpose

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the NOMAC-E2 COC in a large group of women aged 18-50 years.


Condition Intervention Phase
Contraception
Drug: Estradiol and Nomegestrol Acetate Tablets
Drug: Drospirenone and Ethinyl Estradiol Tablets
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE)

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test) [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
  • Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: Yes ]
  • Cycle control as determined by patient [electronic] diaries. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
  • Acceptability will be evaluated on the basis of discontinuation rates and reasons for discontinuation. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • User satisfaction will be evaluated using "Patient Reported Outcome Questionnaires" (self-administered). [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]
  • Acne will be assessed by regular skin examinations. [ Time Frame: One year (13 cycles) ] [ Designated as safety issue: No ]

Enrollment: 2152
Study Start Date: May 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Estradiol and Nomegestrol Acetate Tablets
Drug: Estradiol and Nomegestrol Acetate Tablets
24 active plus 4 placebo tablets per cycle
2: Active Comparator
Drospirenone and Ethinyl Estradiol Tablets
Drug: Drospirenone and Ethinyl Estradiol Tablets
21 active plus 7 placebo tablets per cycle

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sexually active women, at risk for pregnancy and not planning to use condoms;
  • Women in need for contraception and willing to use an 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 Criteria:

  • Contraindications for contraceptive steroids
  • In accordance with the 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], 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: Protocol No. 292001, P05724
Study First Received: August 2, 2007
Last Updated: October 2, 2009
ClinicalTrials.gov Identifier: NCT00511199     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Estradiol 17 beta-cypionate
Reproductive Control Agents
Hormones
Megestrol
Pharmacologic Actions
Estradiol
Contraceptives, Oral, Combined
Aldosterone Antagonists
Therapeutic Uses
Estradiol 3-benzoate
Drospirenone
Contraceptives, Oral, Synthetic
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 27, 2009