About Clinical Research
Study #54023-C

Eligible individuals must willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.

Healthy participants are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for the study.

Eligible individuals must be capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions.

A female participant is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:

• • Postmenopausal females are defined as no menses for 12 months without an alternative medical cause.
  • Is not a WOCBP
  • Premenopausal female with 1 of the following:
    • Documented hysterectomy;
    • Documented bilateral salpingectomy;
    • Documented bilateral oophorectomy.

For individuals with permanent infertility due to a medical cause other than the above (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry.

Is a woman of Child Bearing Potential

• • Highly Effective Methods That Have Low User Dependency:
    • Implantable progestogen only hormone contraception associated with inhibition of ovulation.
    • Intrauterine device.
    • Intrauterine hormone releasing system.
    • Bilateral tubal occlusion.
    • Vasectomized partner:
    • Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual partner of the WOCBP and the absence of sperm has been confirmed.

If not, an additional highly effective method of contraception should be used. The spermatogenesis cycle is approximately 90 days.

• Highly Effective Methods That Are User Dependent:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  • Oral;
  • Intravaginal;
  • Transdermal.
  • Progestogen only hormone contraception associated with inhibition of ovulation:
    • Oral
    • Injectable
  • Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study
    intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.

• Other Effective Methods:
  • Progestogen only oral hormonal contraception where inhibition of ovulation is not the primary mode of action.
  • Male or female condom, with or without spermicide.
  • Cervical cap, diaphragm, or sponge with spermicide.
  • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double barrier methods