HSG and Tubal Patency Study

Inclusion Criteria:

i. Women between 18 and 40 years old ii. In good health, with regular menstrual cycles
that occur 24 - 37 days iii. No current use of hormonal contraception or an intrauterine
device and having had at least one complete menstrual cycle since having stopped hormonal
contraception before starting the treatment.

iv. Have a negative urine pregnancy test at the admission visit. v. Have a negative
chlamydia test at the admission visit. vi. Not be at risk for pregnancy. They will be
consistently using a non-hormonal contraception method, have a surgically sterile male
partner with a vasectomy, be abstinent, or be in a same-sex relationship from the
screening visit through the first study cycle. After starting the combined OC (see Visit
4 below), use of a non-hormonal method is no longer required.

vii. In the opinion of the investigator, willing and able to follow all study
requirements, including use of the approved study medications (doxycycline, oral
contraceptive and DMPA).

viii. Understand and sign an IRB approved inform consent form prior to screening
activities.

ix. Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤145 mm Hg after 5
minutes in sitting position.

x. Agree not to participate in any other clinical trials during the course of this study.

Exclusion Criteria:

- i. Women with menstrual cycle length of less than 24 or more than 37 days; or with
spontaneous irregular menstrual cycle length with intra-individual variations of more
than 5 days ii. Currently pregnant as confirmed by positive high-sensitivity urine
pregnancy test iii. Women planning pregnancy within their months of study
participation iv. Currently breast-feeding or within 30 days of discontinuing breast
feeding v. Current use of a hormonal IUD, or other hormonal contraception (including
oral contraceptives, contraceptive vaginal rings, contraceptive patches, or
contraceptive implants) within 30 days prior to screening. NOTE: Discontinuation of
hormonal contraception or removal of implanted hormonal contraceptives must have been
for personal reasons unrelated to the purpose of enrollment in this study.

vi. Undiagnosed abnormal genital bleeding vii. Known hypersensitivity to radio-opaque
contrast, doxycycline, levonorgestrel, ethinyl estradiol or depo-medroxyprogesterone
acetate. The active ingredients in the approved medications used in the study.

viii. Anomalies in the clinical exam or history done at screening visit recognized as
clinically significant by the investigator.

ix. Unable to pass a uterine sound at the screening examination. x. A positive test for
chlamydia at screening, or a history of a positive test within the last 6 months.

xi. A clinically significant Pap test abnormality, as managed by current local or national
guidelines that would require treatment over the next 6 months.

xii. Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin
cancer) xiii. Body mass index (BMI) >35. xiv. Current use of a non-hormone containing
(copper) intrauterine device (IUD). NOTE: Removal of an IUD must have been for personal
reasons unrelated to the purpose of enrollment in this study.

xv. Smoking if > age 35. xvi. Personal history of venous or arterial thrombosis or
embolism, or family history in a first-degree relative <55 years of age suggesting
familial defect in blood coagulation system, which in the opinion of the principal
investigator, suggests use of a hormonal contraceptive could pose a significant risk.

xvii. Cerebrovascular or cardiovascular disease. xviii. History of retinal vascular
lesions, unexplained partial or complete loss of vision.

xix. Headaches with focal neurological symptoms. xx. History of cholestatic jaundice of
pregnancy or jaundice with prior steroid use.

xxi. Use of liver enzyme inducers on a regular basis. xxii. History of involuntary
infertility, pelvic inflammatory disease (not followed by a normal pregnancy), or known
gynecologic conditions or surgery that could affect tubal patency (e.g. tubal adhesions,
endometriosis, hydrosalpinx, salpingectomy, hysterectomy, oophorectomy).

xxiii. History of a prior HSG showing tubal occlusion on one or both sides.