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Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(COMPLETED)
This study has been completed.
First Received: December 18, 2006   Last Updated: August 22, 2008   History of Changes
Sponsored by: Organon
Information provided by: Organon
ClinicalTrials.gov Identifier: NCT00413062
  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: NOMAC E2
Drug: drospirenone and ethinyl estradiol tablets
Phase III

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen 1,2-Dihydrospirorenone Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate
U.S. FDA Resources
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)

Further study details as provided by Organon:

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 ]

Estimated Enrollment: 2320
Study Start Date: May 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
nomegestrol acetate (NOMAC) and estradiol (E2)
Drug: NOMAC E2
NOMAC-E2 COC (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.
  • 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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers: Organon protocol 292002
Study First Received: December 18, 2006
Last Updated: August 22, 2008
ClinicalTrials.gov Identifier: NCT00413062     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Estrogens
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Estradiol 17 beta-cypionate
Hormones
Estradiol
Contraceptives, Oral, Combined
Aldosterone Antagonists
Estradiol 3-benzoate
Drospirenone
Polyestradiol phosphate

Additional relevant MeSH terms:
Estrogens
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Reproductive Control Agents
Hormones
Estradiol
Pharmacologic Actions
Contraceptives, Oral, Combined
Aldosterone Antagonists
Therapeutic Uses
Drospirenone

ClinicalTrials.gov processed this record on May 07, 2009