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Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
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: NCT00511433
  Purpose

The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive on ovarian function.


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, Pharmacodynamics Study
Official Title: A Randomized, Open-Label, Comparative Trial to Evaluate the Effects on Ovarian Function 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 ug Ethinyl Estradiol (EE)

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Ovarian function as determined by blood sampling (P, FSH, LH and E2), and vaginal USS of the ovaries to assess follicular growth [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Return of ovulation as determined by blood sampling (P levels) and vaginal USS of the ovaries to assess follicular growth [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effects on cervical mucus as determined by Insler score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effects on endometrial thickness as determined by vaginal USS of the endometrium [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effects on androgen, SHBG and folic acid levels as determined by blood sampling. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, and monitoring vital signs. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Cycle control as determined by patient diary records. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Estradiol and Nomegestrol Acetate Tablets (1.5 mg / 2.5 mg)
Drug: Estradiol and Nomegestrol Acetate Tablets
(1.5 mg / 2.5 mg), 6 cycles, tablets
2: Active Comparator
Drospirenone and Ethinyl Estradiol Tablets (3 mg / 30 ug)
Drug: Drospirenone and Ethinyl Estradiol Tablets
(3 mg / 30 ug), tablets

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing to use COC for at least 6 cycles.
  • 18 - 35 years of age at screening.
  • BMI of >/= 17 and </= 35.
  • Good physical and mental health.
  • Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
  • Willing to give informed consent.

Exclusion Criteria:

  • Contraindications for contraceptive steroids (general).
  • Additional contraindications (renal, hepatic or adrenal insufficiency).
  • Breastfeeding.
  • Present use (or use within 2 months prior to 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 post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St. John's Wort0.
  • Administration of any other 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.
  • Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening.
  • Clinically relevant abnormal laboratory result at screening as judged by the investigator.
  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: 292003, P05723
Study First Received: August 2, 2007
Last Updated: October 2, 2009
ClinicalTrials.gov Identifier: NCT00511433     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 February 08, 2010