Clinical trial NCT00511199: Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-08-03
Enrollment: 2152
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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) combined oral contraceptive (COC) in a large group of women aged 18-50 years.


Eligibility 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 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 (BMI) of \>/= 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 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.

Primary outcomes:
measure: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
timeFrame: 1 year (13 cycles)
measure: Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
timeFrame: 1 year (13 cycles)
Secondary outcomes:
measure: Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Breakthrough Bleeding
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Early Withdrawal Bleeding
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Number of Participants With an Occurrence of Continued Withdrawal Bleeding
timeFrame: Every 28-day cycle for 12 cycles
measure: Average Number of Breakthrough Bleeding/Spotting Days
timeFrame: Every 28-day cycle for 13 cycles (one year total)
measure: Average Number of Withdrawal Bleeding/Spotting Days
timeFrame: Every 28-day cycle for 13 cycles (one year total)
Other outcomes:
Locations:
Study officials:
References:
citation: Mansour D, Verhoeven C, Sommer W, Weisberg E, Taneepanichskul S, Melis GB, Sundstrom-Poromaa I, Korver T. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17beta-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care. 2011 Dec;16(6):430-43. doi: 10.3109/13625187.2011.614029. Epub 2011 Oct 13.
citation: Witjes H, Creinin MD, Sundstrom-Poromaa I, Martin Nguyen A, Korver T. Comparative analysis of the effects of nomegestrol acetate/17 beta-estradiol and drospirenone/ethinylestradiol on premenstrual and menstrual symptoms and dysmenorrhea. Eur J Contracept Reprod Health Care. 2015;20(4):296-307. doi: 10.3109/13625187.2015.1016154. Epub 2015 Feb 25.