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AtrophyPhase 2NCT02497547

An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy

A Phase 2 study testing Oxytocin in people with Atrophy, run by PepTonic Medical AB at 5 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Up to 50% of postmenopausal women frequently suffer from atrophic vaginitis or vaginal atrophy with symptoms including vaginal dryness, irritation, burning, itching or discomfort. Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier, and less elastic due to lack of estrogen. Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Atrophy
What is being tested?
Oxytocin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
227 participants
Where
5 sitesSweden
Study dates
Oct 2014to Jul 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To participate in the study, a subject must:
  • Be a female subject between the ages of 40 and 65 years at the time of randomization, who is willing to participate in the study as indicated by signing the informed consent
  • Be a postmenopausal woman with at least 24 months of spontaneous amenorrhea or a woman, who has had surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks ago
  • Have ≤ 5% superficial cells in vaginal smear cytology at screening
  • Have a vaginal pH > 5.0 at screening
  • Have a level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) > 40 milli International Units (mIU)/ml at screening
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  • Have one moderate to severe vaginal atrophy symptom (vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with sexual activity) that has been identified by the subject as being the most bothersome to her
  • Have a Body Mass Index (BMI) ≤32 kg/m2
  • Be judged by the Principal Investigator or Sub-investigator as being in otherwise good health based on a pre-study medical evaluation performed within 35 days prior to the initial dose of study medication
  • Have endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in women with an intact uterus
  • Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and at Visits 2 and 3

Who cannot join

  • To participate in the study, a subject must not:
  • Be currently hospitalized
  • Have a history of ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator
  • Have had or have any known or suspected tumor disease that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator
  • Have a history of endometrial hyperplasia or uterine/endometrial, breast or ovarian cancer
  • Have a history of undiagnosed vaginal bleeding
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  • Have an ongoing urogenital infection at randomization visit
  • Any contraindication to oxytocin therapy and allergy to the use of oxytocin and any components of the investigational drugs
  • Have a history of drug and/or alcohol abuse within one year of start of study
  • Have used any prescription or Over The Counter (OTC) medications including phytoestrogens, herbal medicinal products or hormonal intra-uterine device with known estrogenic effects within 12 weeks prior to screening procedures
  • Have used any type of vaginal lubricants and moisturizers within 24 hours prior to screening procedures
  • Have used estrogen alone or estrogen/progestin for any of the time periods specified in the protocol
  • Have any reason, which in the opinion of the Principal Investigator or Sub-Investigator would prevent the subject from safely participating in the study or complying with protocol requirements
  • Have participated in another clinical trial within 90 days prior to screening, have received an investigational drug within the three months prior to the initial dose of study medication, or be likely to participate in a clinical trial or receive another investigational medication during the study
  • Have contraindication to any planned study procedure

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Sweden5 sites

  • Hoftekliniken

    Helsingborg, 252 21

  • Qvinnolivet Specialistläkarna Kungsbacka

    Kungsbacka, 434 30

  • Kvinnoforskningsenheten, Karolinska Universitetssjukhuset, Huddinge

    Stockholm, 141 86

  • Kvinnokliniken, Norrlands Universitetssjukhus

    Umeå, 901 85

  • Kvinnokliniken, Akademiska sjukhuset

    Uppsala, 751 85

Other trials in Sweden

About this study

Official title: A Phase 2b, Double-blind, Randomized, Parallel, Placebo-Controlled, Multiple-Dose Study to Evaluate the 12-week Efficacy of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy

Up to 50% of postmenopausal women frequently suffer from atrophic vaginitis or vaginal atrophy with symptoms including vaginal dryness, irritation, burning, itching or discomfort. Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier, and less elastic due to lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections.

Menopausal hormone therapy is a common treatment for vaginal atrophy. However, menopausal hormone therapy has been shown to coincide with an increased incidence of breast cancer, heart attack and stroke. Some women experience adverse reactions such as uterine bleeding, perineal pain, and breast pain with menopausal hormone therapy. Many women are also reluctant to initiate estrogen treatment, due to a general negative view of menopausal hormone therapy in the society. There are also many contraindicated conditions like undiagnosed vaginal bleeding, thromboembolic disease, breast cancer, other estrogen-sensitive cancers, or liver disease. Women suffering from vaginal atrophy and presenting with these conditions have extremely limited options for effective therapy.

Read more

Oxytocin is a peptide hormone, normally released into the circulation via the pituitary. Oxytocin has been shown in vitro to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women. Local application of oxytocin, in the form of a vaginal gel, Vagitocin, has been investigated in previous studies on postmenopausal women, as a new effective and safe option for the treatment of vaginal atrophy. Vagitocin appeared to reverse the manifestation of vaginal atrophy by stimulating vaginal mucosal growth, reducing symptoms of vaginal atrophy and increasing the patients' wellbeing and quality of life. Overall, treatment with Vagitocin was safe and well tolerated by the subjects in the studies.

In this study, the clinical efficacy of Vagitocin as a potential treatment for postmenopausal women suffering from moderate to severe symptoms of vaginal atrophy, vaginal irritation/itching and vaginal discomfort and/or pain associated with sexual activity will be explored. In addition, the dose relationship and lowest effective dose of Vagitocin will be investigated.

Conditions
Atrophy
Being tested
Oxytocin, Placebo
Keywords
Atrophy, Pathological Conditions, Anatomical, Oxytocin, Oxytocics
Medical subject headings
Atrophy, Pathological Conditions, Anatomical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxytocinDrug

    Also called Vagitocin

  • PlaceboDrug

Study groups in NCT02497547
Study groupRoleWhat they receive
Oxytocin 400 IUExperimentalOxytocin 400 IU vaginal gel (1 x 1mL/400 IU oxytocin daily for 12 weeks)
Receives: Drug: Oxytocin
Oxytocin 200 IUExperimentalOxytocin 200 IU vaginal gel (1 x 1mL/200 IU oxytocin daily for 12 weeks)
Receives: Drug: Oxytocin
PlaceboPlacebo comparatorPlacebo vaginal gel (1 x 1mL daily for 12 weeks)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to Week 12 in severity of vaginal atrophy symptom that has been self-identified by the subject as being the most bothersome to her in the vaginal atrophy questionnaire

    Vaginal atrophy symptoms: vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with sexual activity

    Measured: After 12 weeks of treatment

  2. Change from baseline to Week 12 in % superficial cells (increase is positive)

    Measured: After 12 weeks of treatment

  3. Change from baseline to Week 12 in Vaginal pH (decrease is positive)

    Measured: After 12 weeks of treatment

Secondary outcomes (7)

  1. Change from baseline to Week 4 in severity of the vaginal atrophy symptoms that has been self-identified by the subject as being the most bothersome to her in the vaginal atrophy questionnaire

    Vaginal atrophy symptoms: vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria and the absence or presence of vaginal bleeding associated with sexual activity

    Measured: After 4 weeks of treatment

  2. Change from baseline to Week 4 in % superficial cells (increase is positive)

    Measured: After 4 weeks of treatment

  3. Change from baseline to Week 4 in vaginal pH (decrease is positive)

    Measured: After 4 weeks of treatment

  4. Change from baseline to week 4 and 12 of % parabasal cells (decrease is positive)

    Measured: After 4 and 12 weeks of treatment

  5. Change from baseline to week 4 and 12 of maturation value (increase is positive)

    Measured: After 4 and 12 weeks of treatment

  6. Change from baseline to Weeks 4 and 12 in severity of vaginal atrophy symptoms self-assessed by the subject in the vaginal atrophy questionnaire

    Vaginal atrophy symtoms: vulvar and vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria and the absence or presence of vaginal bleeding associated with sexual activity

    Measured: After 4 and 12 weeks of treatment

  7. Change from baseline to Week 12 in Quality of Life evaluation parameters

    Measured: After 12 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02497547
Sponsor's protocol ID
OXYPEP201
Status last verified
Oct 2015
First submitted
6 Jul 2015
Last updated
21 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxytocin in people with Atrophy, run by PepTonic Medical AB at 5 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to Week 12 in severity of vaginal atrophy symptom that has been self-identified by the subject as being the most bothersome to her in the vaginal atrophy questionnaire (time frame: After 12 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02497547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.

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