Vaginal ring dysmenorrhea feasibility trial.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 450

Inclusion Criteria

1. Subject must be willing and able to provide written informed consent for the trial.
2. Subject must be female.
3. Subject must be ?18 to ?50 years of age.
4. Subject must have a body mass index (BMI) =18 and =35.
5. Subject must have an established diagnosis of primary dysmenorrhea, characterized by menstrual pain in the absence of detectable pelvic pathology (eg, endometriosis, fibroids, pelvic inflammatory disease).
6. Each non-sterilized sexually active subject of child-bearing potential must agree to use condoms for contraception during the entire screening period, treatment period, and post-treatment period until the final study visit.
7. Subject using a hormonal contraceptive (combined or progestin-only), or a non-hormonal IUD, at the screening visit must agree to stop using that method.
8. Subject has regular menstrual cycles ranging from 24 to 32 days in length (to be confirmed at the randomization visit following completion of a baseline menstrual cycle).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has any contraindication to the use of contraceptive steroids.
2. Subject has secondary dysmenorrhea – ie, menstrual pain in the presence of detectable pelvic pathology (eg, endometriosis, fibroids, pelvic inflammatory disease).
3. Subject has not had spontaneous menstruation following a delivery or abortion at the screening visit.
4. The subject is breastfeeding or has not had spontaneous menstruation following completion of breastfeeding at the screening visit.
5. Subject has a history of malignancy =5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
6. Subject had a documented abnormal cervical smear result within 6 months prior to the screening visit.
7. Subject routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking.