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

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:

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate TX 066 Nomegestrol Depogen 1,2-Dihydrospirorenone Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

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